Regu®-Fade - Product Dossier

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Personal Care

Product Dossier

REGU®-FADE
Product Code: 5015131

© DSM Nutritional Products Ltd., 2023


Regulatory Affairs & Quality Management Personal Care & Aroma Compilation Date: 14.04.2023
PO Box 2676 Previous Compilation Date: 13.04.2023
CH-4002 Basel/Switzerland
Table of Contents
Below are listed all available Statements and Technical Data Sheets, listed by name and by
section order as per the Product Dossier.
Additional data is provided in the Technical Dossier document chapters 1-9.

To navigate in the dossier, please activate the bookmark bar of your PDF reader.
Please note that some chapters of the technical dossier might not be listed in the table of
contents. In such cases, statements belonging to the respective chapter are not available.

Technical data sheets

Product Data Sheet

Representative Composition

Manufacturing Principle

Specifications & Test

Technical dossier

Technical Dossier document

1. Source of ingredient(s)

GMO statement

BSE/TSE statement

3. Substance(s) potentially contained

Residual solvents

Pesticide statement

4. Regulatory information

Compliance confirmation

Fragrance allergen statement

CMR statement

Animal testing statement

© DSM Nutritional Products Ltd., 2023


Regulatory Affairs & Quality Management Personal Care & Aroma Compilation Date: 14.04.2023
PO Box 2676 Previous Compilation Date: 13.04.2023
CH-4002 Basel/Switzerland
REACh statement

SVHC statement

California proposition 65 statement

China regulatory status

Global regulatory status

5. Safety and Environment

Toxicological information statement

7. Packaging materials

Compliance of packaging materials statement

Traceability of packaging materials statement

9. Supportive documentation

Sustainability document

Lot code explanation

10. Additional information

Glossary Technical Dossier

This document is generated electronically and valid without signature.


Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume
full responsibility according to the relevant local regulations. The content of this document is subject to change without further
notice unless otherwise agreed in writing. Please consult your local representative or visit the DSM Portal at
https://nutritionportal.dsm.com for the latest version of this document or the latest information.

© DSM Nutritional Products Ltd., 2023


Regulatory Affairs & Quality Management Personal Care & Aroma Compilation Date: 14.04.2023
PO Box 2676 Previous Compilation Date: 13.04.2023
CH-4002 Basel/Switzerland
Product Information
Product Data Sheet

REGU®-FADE
Product code: 5015131

Description
REGU®-FADE is a preservative free, pesticide free, nature identical trans-resveratrol, with
extraordinary purity and safety profiles that offers multifunctional, excellent skin lightening
properties for a radiant and youthful looking skin.
Product Identification
Product code: 5015131
Chemical name: 5-[(1E)-2-(4-Hydroxyphenyl) ethenyl]-1,3-benzenediol
INCI name: Resveratrol
OH
CAS No: 501-36-0
Empirical formula: C14H12O3 HO

Molecular mass: 228.25 g/mol

Specifications OH

Appearance: powder
Color: off-white to beige
Identity: corresponds
Heavy metals (as lead): max. 10 ppm
Arsenic: max. 1.0 ppm
Assay: min. 99% trans-resveratrol
Total Viable Aerobic Count:
Total Aerobic Microbial Count (TAMC): ≤ 100 CFU / g
Total Yeast/Molds Count (TYMC): ≤ 100 CFU / g
Specified microorganisms: absence in 1 g

Solubility
REGU®-FADE is almost insoluble in water and in lipophilic components. REGU®-FADE can be
dissolved in PEG/PPG containing solubilizers.
Long term solubility and stability is dependent on the whole cosmetic formulation. For full
details please refer to the document 'Formulation Guidelines REGU®-FADE'.

DSM Nutritional Products Ltd., Wurmisweg 576, CH-4303 Kaiseraugst Switzerland


© DSM Nutritional Products Ltd., 2021 Version 05: 2021-10-07
Replaces Version 04: 2021-07-05
Page 1 of 3
Product Information
Product Data Sheet

REGU®-FADE
Product code: 5015131

Stability and Storage


REGU®-FADE may be stored for at least 60 months from the date of manufacture in the
unopened original container and at a temperature below 25°C. The ‘best use before’ date is
printed on the label. Keep container tightly closed. Once opened, use contents quickly.

Uses
In Skin Care applications REGU®-FADE is recommended for use in O/W, W/O or Si/W
formulations, toners, as well as in gel product forms up to 1%.
REGU®-FADE is heat stable, and can be effectively used over a broad pH range (3-6.5). It should
be pre-solubilized in Propylene Glycol, Ethanol or similar solubilizers at elevated temperature
(~50°C) before adding to the formulations. Exposure of the final formulations to direct sun light
should be avoided (use opaque packaging). The addition of UV-filters is recommended for day
care products.

Safety
This product is safe for the intended use. Avoid ingestion, inhalation of dust or direct contact
by applying suitable protective measures and personal hygiene.
For full safety information and necessary precautions, please refer to the respective DSM
Material Safety Data Sheet.

DSM Nutritional Products Ltd., Wurmisweg 576, CH-4303 Kaiseraugst Switzerland


© DSM Nutritional Products Ltd., 2021 Version 05: 2021-10-07
Replaces Version 04: 2021-07-05
Page 2 of 3
Product Information
Product Data Sheet

REGU®-FADE
Product code: 5015131

Additional information
To find out more about our ingredients, please contact your nearest DSM Nutritional Products
office.

DSM Nutritional Products Ltd Tel.: +41 (0) 61 815 8899


Product Management Internet www.dsmnutritionalproducts.com
Building 241
PO Box 2676
CH-4002 Basel
Switzerland

DSM Nutritional Products LLC Tel.: +1 (800) 526 0189 (Human Nutrition, Personal Care)
45 Waterview Boulevard Tel.: +1 (800) 451-8325 (Animal Nutrition)
Parsippany, NJ 07054-1298 Internet www.unlimitednutrition-na.dsm.com

DSM Nutritional Products Europe Ltd. Tel.: +41 (0) 61 815 7777
PO Box 2676 Internet www.unlimitednutrition-eu.dsm.com
CH-4002 Basel
Switzerland

DSM Singapore Industrial Pte Ltd. Tel.: + (65) 66326500


trading as DSM Nutritional Products Asia Pacific Internet www.dsmnutritionalproducts.com
30 Pasir Panjang Road #13-31
Mapletree Business City
Singapore 117440

DSM Nutritional Products China Tel.: + 86 (0)21 6141 8188


No. 476, Li Bing Road Internet www.dsmnutritionalproducts.cn
Zhangjiang High-Tech Park
Pudong Area, Shanghai 201203
P.R. of China

DSM Produtos Nutricionais Brasil S.A. Tel.: + 55 (11) 3760-6300


Avenida Engenheiro Billings, nº 1729 – Prédio 31 Internet www.dsmnutritionalproducts.com
Sala A
CEP:05321-010
São Paulo – SP
Brasil

This document is valid without signature.


Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume full
responsibility according to the relevant local regulations. The content of this document is subject to change without further notice
unless otherwise agreed in writing. Please consult your local representative or one of DSM‘s websites at https://webshop.dsm.com for
the latest version of this document or the latest information.

DSM Nutritional Products Ltd., Wurmisweg 576, CH-4303 Kaiseraugst Switzerland


© DSM Nutritional Products Ltd., 2021 Version 05: 2021-10-07
Replaces Version 04: 2021-07-05
Page 3 of 3
Product Information
Representative Composition

REGU®-FADE
Product Code: 5015131

This statement provides information about the representative product composition for Personal Care
Customers.

INCI Name Content %

Resveratrol 100.00
Total 100.00

The values must not be interpreted as a specification. The product specification is provided in the
Product Data Sheet.

This document is generated electronically and valid without signature.


Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume full
responsibility according to the relevant local regulations. The content of this document is subject to change without further notice
unless otherwise agreed in writing. Please consult your local representative or visit the DSM Portal at https://nutritionportal.dsm.com
for the latest version of this document or the latest information.

DSM Nutritional Products Ltd., Wurmisweg 576, CH-4303 Kaiseraugst Switzerland NUTRITION • HEALTH • SUSTAINABLE LIVING
© DSM Nutritional Products Ltd., 2023 Version 01: 2023-04-12
Replaces Version NEW:

Page 1 of 1
Product Inf ormat ion

REGU®-FADE

Manufacturing Principle

Wit t ig react ion of phosphonat e est er wit h 4 met hoxy benzaldehyde in presence of sodium
hydride f oll owed by purif icat ion af f ords t he Trimet hoxyresverat rol which on dealkylat ion of
wit h aluminium chloride and amine f oll owed by cryst allizat ion f rom isopropanol . Wat er and
f inal recryst allizat ion from et hanol / wat er af f ords pure Resverat rol.

OMe
PO(OEt)2
OMe OMe OMe
+
NaH, solvents
OHC
OMe OMe
Phosphonate ester 4-Methoxybenzaldehyde Trimethoxyresveratrol

OMe OH

OMe HO

1. AlCl3 ,amine

2. ethanol, water
OMe OH

Trimethoxyresveratrol RESVERATROL

This document is gener at ed elect ronically and valid wit hout signat ure.
Disclaimer: The infor mat ion cont ained her ein is t o t he best of our knowledge accur at e. However , we refuse any l iabil it y f or t he
applicat ion and use of f urt her processed mat eri al cont aining our pr oduct . Solel y t he producer of t he f inal product has t o assume
f ull responsibilit y accor ding t o t he relevant local regul at ions. The cont ent of t his document is subj ect t o change wi t hout f urt her
not ice unless ot herw ise agreed in wr it ing. Please consult your local represent at ive or one of DSM‘ s websit es at
ht t ps:/ / webshop.dsm.com f or t he lat est version of t his document or t he lat est inf or mat ion.

DSM Nut r it ional Product s Lt d. Product Code: 50 1513 1


Version 01: 2013-06-26
Global Qualit y Management OPS/ QM
Replaces ver sion: new
P. O. Box 2676, CH-4002 Basel , Sw it zerland Ref : SbI/ MC
Page 1 of 1
Product Information
Specifications & Tests

REGU®-FADE
Product code: 5015131

1. Appearance: powder

2. Colour off white to beige

3. Identity corresponds
The identity test is performed by IR.

4. Heavy metals: max. 10 ppm


Proceed according to the test described in the general part of Ph.Eur. 2.2.23, Atomic
Absorption Spectrometry.

5. Arsenic: max. 1.0 ppm


Proceed according to the test described in the general part of Ph.Eur. 2.2.23, Atomic
Absorption Spectrometry.

6. Assay min. 99% trans-Resveratrol (w/w)


HPLC parameters (e.g. for Agilent 1100 Series)
o Stationary phase: C18 reversed phase
(e.g. YMC-Pack Pro C18, S-3 µm, 120 Å;
Order code: A512S03-1546WT, AS-302-3)
o Column dimensions (length x internal diameter): 150 x 4.6 mm
o Mobile phase A: phosphoric acid 0.1% in water
o Mobile phase B: Acetonitrile
o Flow rate: 1.0 mL/min
Wave length: 240 nm
o Injector draw speed: 50L
o Injection volume: 2 μL
o Running time: 30 min
o Post-run: 10 min

DSM Nutritional Products Ltd., Wurmisweg 576, CH-4303 Kaiseraugst Switzerland


© DSM Nutritional Products Ltd., 2021 Version 03: 2021-07-05
Replaces Version 02: 2020-09-25
Page 1 of 3
Product Information
Specifications & Tests

REGU®-FADE
Product code: 5015131

o Column temperature: 25°C

Gradient
Time [min] %A %B Flow Wavelength Notes
[mL/min] [nm]
0 80 20 1 240
2 80 20 1 240
20 5 95 1 240
30 5 95 1 240 Stop
35 80 20 1 240 Post-run

o Sample solution

Dissolve 35 – 45 mg of the substance (exactly weighed) in a 100 mL volumetric flask in


methanol.

It is important to use amber glassware!

o Calculation

m S D
  c RS  D f
m S D
m = trans-resveratrol MRS weighed into the stock solution MRS, in grams,
m = sample weighed into the stock solution sample, in grams,
SD = peak area for trans-resveratrol in the chromatogram of the injection solution
sample,
S D = peak area for trans-resveratrol in the chromatogram of the injection solution
MRS,
c RS
= trans-resveratrol content in the trans-resveratrol MRS, in percent,
Df
= dilution factor (= 2).

DSM Nutritional Products Ltd., Wurmisweg 576, CH-4303 Kaiseraugst Switzerland


© DSM Nutritional Products Ltd., 2021 Version 03: 2021-07-05
Replaces Version 02: 2020-09-25
Page 2 of 3
Product Information
Specifications & Tests

REGU®-FADE
Product code: 5015131

o Dilution factor

1 10 200 50
* *   2.0
100 50 1 10

7. Total Viable Aerobic Count

According to the EP 2.6.12, membrane filtration or pour plate


- Total Aerobic Microbial Count (TAMC): ≤ 100 CFU / g
- Total Yeast/Moulds Count (TYMC): ≤ 100 CFU / g

8. Specified microorganisms:
According to the EP 2.6.13 or equivalent validated method
Pseudomonas aeruginosa absence in 1 g
Staphylcoccus aureus absence in 1 g
Candida albicans absence in 1 g
Escherichia coli absence in 1 g

This document is valid without signature.


Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume full
responsibility according to the relevant local regulations. The content of this document is subject to change without further notice
unless otherwise agreed in writing. Please consult your local representative or one of DSM‘s websites at https://webshop.dsm.com for
the latest version of this document or the latest information.

DSM Nutritional Products Ltd., Wurmisweg 576, CH-4303 Kaiseraugst Switzerland


© DSM Nutritional Products Ltd., 2021 Version 03: 2021-07-05
Replaces Version 02: 2020-09-25
Page 3 of 3
Product Information
Technical Dossier

REGU®-FADE
Product Code: 5015131

1. Source of ingredient(s)

Source of active ingredient(s) Yes No Comments


Synthetic X Resveratrol
Biotechnology X
Vegetable X
Animal X
Mineral X

Source of formulation ingredient(s) Yes No Comments


Synthetic Not applicable
Biotechnology Not applicable
Vegetable Not applicable
Animal Not applicable
Mineral Not applicable

Additional ingredient(s) source information Yes No Comments


GMO statement available X
BSE/TSE statement available X
Palm oil or palm oil derived X
Petroleum derived X Resveratrol

Ionisation / Irradiation Yes No Comments


Ionisation or irradiation applied to this product X

DSM Nutritional Products Ltd., Wurmisweg 576, CH-4303 Kaiseraugst Switzerland NUTRITION • HEALTH • SUSTAINABLE LIVING
© DSM Nutritional Products Ltd., 2022 Version 03: 2022-06-02
Replaces Version 02: 2018-02-05
Page 1 of 7
Product Information
Technical Dossier

REGU®-FADE
Product Code: 5015131

2. Function of the ingredient(s)

Function Yes No Comments


Active substance(s) X Resveratrol (antioxidant, skin protectant)
Solvent(s) / carrier(s) X
Antioxidant(s) X
Ingredient(s) listed in Annexes (II, III, IV, V, VI) of X
Cosmetic Regulation (EC) 1223/2009
Others Not applicable

3. Substance(s) potentially contained

Food allergens Yes No Comments


Cereals containing gluten and products thereof Not applicable
Milk and dairy products (incl. lactose) Not applicable
Nuts and nut products (incl. peanuts) Not applicable
Coconut and products thereof Not applicable

DSM Nutritional Products Ltd., Wurmisweg 576, CH-4303 Kaiseraugst Switzerland NUTRITION • HEALTH • SUSTAINABLE LIVING
© DSM Nutritional Products Ltd., 2022 Version 03: 2022-06-02
Replaces Version 02: 2018-02-05
Page 2 of 7
Product Information
Technical Dossier

REGU®-FADE
Product Code: 5015131

Other various substances Yes No Comments


Ethanol and denatured alcohol X See Residual Solvents Statement
Formaldehyde and formaldehyde releasers X Not expected and not determined
Acetaldehyde X Not expected and not determined
Phthalates X Not expected and not determined
Glycol ethers X Not expected and not determined
1,4-Dioxane X Not expected and not determined
Free amines X Diisopropylamine (DIPA) max. 10 ppm
(processing aid, see Manufacturing
Principle)
Nitrosamines X NDIPA max. 10 ppb (LOQ)
Acrylamide X Not expected and not determined
Monomer residues X Not expected and not determined
Dioxin/PCB X Not expected and not determined
PAH(s) X Not expected and not determined
Heavy metals statement (SP) X See Product Data Sheet
Residual solvents statement available X See Residual Solvents Statement
Pesticide statement available X

4. Regulatory information

EU cosmetic legislation (Reg (EC) 1223/2009) Yes No Comments


Compliance statement available X
Fragrance allergen statement available X
CMR statement available X
Animal testing statement available X
Last animal testing date for cosmetic purpose X Neither the product nor its ingredients
have been tested on animals for cosmetic
purposes, by or on behalf of DSM
Nutritional Products Ltd.
Last animal testing date for non-cosmetic X See Animal testing statement
purpose

DSM Nutritional Products Ltd., Wurmisweg 576, CH-4303 Kaiseraugst Switzerland NUTRITION • HEALTH • SUSTAINABLE LIVING
© DSM Nutritional Products Ltd., 2022 Version 03: 2022-06-02
Replaces Version 02: 2018-02-05
Page 3 of 7
Product Information
Technical Dossier

REGU®-FADE
Product Code: 5015131

EU chemical legislation (Reg (EC) 1907/2006) Yes No Comments


REACh statement available X
PBT/vPvB Information X For any available information see Safety
Data Sheet, section 12.5
SVHC statement available X

US Legislation Yes No Comments


Californian Proposition 65 statement available X

China Legislation Yes No Comments


China regulatory status statement available X NMPA SUBMISSION CODE 001152-00666-
7759

Global regulatory overview Yes No Comments


Global regulatory status statement available X

Nanomaterial information Yes No Comments


Nano statement (Reg (EC) 1223/2009) available Not applicable: The product does not
contain nano material according to the
definition of Regulation (EC) No 1223/2009
(Article 2, (k)).
Nano declaration information Not applicable
Additional nano information Not applicable

Other confirmations Yes No Comments


Compendia compliance Not applicable
Cites listed X
In scope of Nagoya Protocol X Product launched before ratification of
Nagoya Protocol (October 2014)

DSM Nutritional Products Ltd., Wurmisweg 576, CH-4303 Kaiseraugst Switzerland NUTRITION • HEALTH • SUSTAINABLE LIVING
© DSM Nutritional Products Ltd., 2022 Version 03: 2022-06-02
Replaces Version 02: 2018-02-05
Page 4 of 7
Product Information
Technical Dossier

REGU®-FADE
Product Code: 5015131

5. Safety and environment

Toxicology Yes No Comments


Toxicological information statement available X
Ecotoxicological information available X For any available information see Safety
Data Sheet, section 12

Volatile organic compound(s) Yes No Comments


VOC substance(s) according to positive list of X
Swiss VOC Regulation contained

6. Product suitability

Eco certification Yes No Comments


Ecocert certificate available Not applicable
Natrue certificate available Not applicable
Cosmos certificate available Not applicable
Fair Trade certificate available Not applicable

Kosher / Halal status Yes No Comments


Kosher certificate/statement available X Not assessed
Halal certificate/statement available X Available on request

7. Packaging materials

Packaging compliance Yes No Comments


Traceability of packaging materials statement X
available
Compliance of packaging materials statement X
available
Treatment of pallets statement available X The pallets are heat-treated according to
IPPC Standard ISPM-15.

DSM Nutritional Products Ltd., Wurmisweg 576, CH-4303 Kaiseraugst Switzerland NUTRITION • HEALTH • SUSTAINABLE LIVING
© DSM Nutritional Products Ltd., 2022 Version 03: 2022-06-02
Replaces Version 02: 2018-02-05
Page 5 of 7
Product Information
Technical Dossier

REGU®-FADE
Product Code: 5015131

8. Quality information

Quality standards Yes No Comments


GMP standard applied for this product X EFfCI GMP (2012) certified

9. Supportive documentation

General statements Yes No Comments


Microbiology statement available X See Product Data Sheet
Sustainability document available X
Lot code explanation available X

DSM Nutritional Products Ltd., Wurmisweg 576, CH-4303 Kaiseraugst Switzerland NUTRITION • HEALTH • SUSTAINABLE LIVING
© DSM Nutritional Products Ltd., 2022 Version 03: 2022-06-02
Replaces Version 02: 2018-02-05
Page 6 of 7
Product Information
Technical Dossier

REGU®-FADE
Product Code: 5015131

10. Additional information

Technical Dossier Yes No Comments

Glossary Technical Dossier available X

Origin India

This document is valid without signature.


Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume full
responsibility according to the relevant local regulations. The content of this document is subject to change without further notice unless
otherwise agreed in writing. Please consult your local representative or one of DSM‘s websites at https://nutritionportal.dsm.com for the
latest version of this document or the latest information.

DSM Nutritional Products Ltd., Wurmisweg 576, CH-4303 Kaiseraugst Switzerland NUTRITION • HEALTH • SUSTAINABLE LIVING
© DSM Nutritional Products Ltd., 2022 Version 03: 2022-06-02
Replaces Version 02: 2018-02-05
Page 7 of 7
Product Information

REGU®-FADE

GMO Statement

We hereby confirm that the product REGU®-FADE is manufactured by conventional processes** and
therefore does not contain GMO-DNA.

** The term "conventional process" refers to chemical synthesis, fermentation using non GMM, extraction from conventional plants.

This document is generated electronically and valid without signature.


..........................................................................................................................................................................................................................
Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume full
responsibility according to the relevant local regulations. The content of this document is subject to change without further notice unless
otherwise agreed in writing. Please consult your local representative or one of DSM's websites at http://webshop.dsm.com for latest
version of this document or the latest information.

DSM Nutritional Products Ltd. Product Code: 50 1513 1


Global Quality Management Page 1 of 1 Date: 2013-May-08
P.O. Box 2676, CH-4002 Basel, Switzerland Reference: Sbl/HNE
Product Information
BSE/TSE Statement

REGU®-FADE
Product code: 5015131

With regards to TSE/BSE potential risk transmission, the EU Cosmetic Products Regulation (EC)
1223/2009 prohibits the use of below materials in cosmetic products:

• Annex II, entry 416: Cells, tissues or products of human origin


• Annex II, entry 419: Category 1 and Category 2 materials as defined in Articles 8 and
9 of Regulation (EC) 1069/2009 (repealing Articles 4 and 5 respectively of Regulation
(EC) No 1774/2002). Category 1 materials include all Specified Risk Materials as
defined by Annex V of Regulation (EC) 999/2001.

We hereby confirm that this product is not derived from animal or human, furthermore no
animal or human origin material is used during the manufacture of this product.

This document is valid without signature.


Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume full
responsibility according to the relevant local regulations. The content of this document is subject to change without further notice
unless otherwise agreed in writing. Please consult your local representative or one of DSM‘s websites at https://webshop.dsm.com for
the latest version of this document or the latest information.

DSM Nutritional Products Ltd., Wurmisweg 576, CH-4303 Kaiseraugst Switzerland


© DSM Nutritional Products Ltd., 2019 Version 02: 2019-02-04
Replaces Version 01: 2013-05-08
Page 1 of 1
Product Information
Residual Solvent Statement

REGU®-FADE
Product code: 5015131

We hereby confirm that REGU®-FADE fully complies with

• ICH guideline for residual solvents Q3C (R8)

• Chemical test <467> of USP/NF: Residual Solvents Limits

• General chapter 5.4 <Residual solvents> and Limit test 2.4.24 of Ph.Eur.: <Identification
and control of residual solvents>

Only Class 2 and Class 3 solvents are likely to be present; residual Class 2 solvents are below
the option 1 limit and residual Class 3 solvents are below 0.5 per cent.
The following limits are met:

Solvent Limit
(mg/kg)
Isopropanol 150
Ethanol 1500
Toluene 50
Tetrahydrofuran 50
Ethyl Acetate 50
Methanol 50

This document is valid without signature.


Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume full
responsibility according to the relevant local regulations. The content of this document is subject to change without further notice
unless otherwise agreed in writing. Please consult your local representative or one of DSM‘s websites at
https://nutritionportal.dsm.com for the latest version of this document or the latest information.

DSM Nutritional Products Ltd., Wurmisweg 576, CH-4303 Kaiseraugst Switzerland


© DSM Nutritional Products Ltd., 2021 Version 04: 2021-06-20
Replaces Version 03: 2019-02-15
Page 1 of 1
Product Information

REGU®-FADE

Pesticide Statement
This confirmation refers to the definition and limits of pesticide residues as laid down in the international
pharmaceutical or food regulations, such as the European Pharmacopoeia or Regulation (EC) No
396/2005¹, applying to ingredients derived from vegetable sources.
Above mentioned product does not contain any ingredient of vegetable origin.
We, therefore, confirm that the product is not expected to contain any pesticide residues.

¹ Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels
of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC and subsequent
amendments.

This document is generated electronically and valid without signature.


Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume full
responsibility according to the relevant local regulations. The content of this document is subject to change without further notice
unless otherwise agreed in writing. Please consult your local representative or one of DSM‘s websites at https://webshop.dsm.com for
the latest version of this document or the latest information.

© DSM Nutritional Products Ltd., 2015 Product Code: 5015131


Global Regulatory Affairs & Quality Management Personal Care Version Date: 10.12.2015
PO Box 2676 Replaces Version: New Document
CH-4002 Basel/Switzerland Ref: DM/CFJ
Page 1 of 1
Product Information

REGU®-FADE

Compliance confirmation
We hereby confirm that the above mentioned product at the DSM recommended applications and the use
levels, conforms to all the requirements laid down for cosmetic ingredients in the Regulation (EC) No
1223/2009¹ on cosmetic products.

This includes the compliance with:


1. Article 14.1. (a) of this Regulation which relates to the absence of prohibited substances as listed in
Annex II
2. Article 14.1. (b) of this Regulation which relates to the absence of restricted substances if not used
in accordance with the restrictions laid down in Annex III
3. Article 17 of this Regulation which relates to the allowance of traces of banned substances under
the condition that they are technically unavoidable in good manufacturing practices and do not
cause damage to human health when applied under normal or reasonably foreseeable conditions of
use.

¹ and subsequent amendments

This document is generated electronically and valid without signature.


Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume full
responsibility according to the relevant local regulations. The content of this document is subject to change without further notice
unless otherwise agreed in writing. Please consult your local representative or one of DSM‘s websites at https://webshop.dsm.com for
the latest version of this document or the latest information.

© DSM Nutritional Products Ltd., 2015 Product Code: 5015131


Global Regulatory Affairs & Quality Management Personal Care Version Date: 03.06.2016
PO Box 2676 Replaces Version: 13.01.2016
CH-4002 Basel/Switzerland Ref: AGG/CFJ
Product Information

REGU®-FADE

Fragrance Allergen Statement


Regulation (EU) 1223/2009 and subsequent amendments, lists a number of substances that may cause
allergic reactions following dermal application in sensitized individuals. These substances have to be
stated in the ingredients list if present at specified levels in the finished cosmetic product.
We hereby confirm that none of the potential fragrance allergens¹ is intentionally added and not expected
to be present in this product.

¹ see annexed list

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Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume full
responsibility according to the relevant local regulations. The content of this document is subject to change without further notice
unless otherwise agreed in writing. Please consult your local representative or one of DSM‘s websites at https://webshop.dsm.com for
the latest version of this document or the latest information.

©DSM Nutritional Products Ltd., 2019 Product Code: 5015131


Global Regulatory Affairs & Quality Management, Personal Care & Aroma Ingredients Version Date: 01.09.2020
PO Box 2676 Replaces Version: 30.06.2020
CH-4002 Basel/Switzerland Ref: LLC
Page 1 of 2
Product Information

List of potential fragrance allergens as listed in Regulation (EC) 1223/2009 and subsequent
amendments:

Ingredient name CAS number(s)


Alpha-Isomethyl Ionone 127-51-5
Amyl Cinnamal 122-40-7
Amylcinnamyl Alcohol 101-85-9
Anise Alcohol 105-13-5
Benzyl Alcohol 100-51-6
Benzyl Benzoate 120-51-4
Benzyl Cinnamate 103-41-3
Benzyl Salicylate 118-58-1
Butylphenyl Methylpropional 80-54-6
Cinnamal 104-55-2
Cinnamyl Alcohol 104-54-1
Citral 5392-40-5
Citronellol 106-22-9
Coumarin 91-64-5
Eugenol 97-53-0
Evernia Prunastri (oakmoss) Extract 90028-68-5
Evernia Furfuracea (treemoss) Extract 90028-67-4
Farnesol 4602-84-0
Geraniol 106-24-1
Hexyl Cinnamal 101-86-0
Hydroxycitronellal 107-75-5
Isoeugenol 97-54-1
Limonene (sum of d, l and dl) 5989-27-5
Linalool 78-70-6
Methyl 2-Octynoate 111-12-6

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application and use of further processed material containing our product. Solely the producer of the final product has to assume full
responsibility according to the relevant local regulations. The content of this document is subject to change without further notice
unless otherwise agreed in writing. Please consult your local representative or one of DSM‘s websites at https://webshop.dsm.com for
the latest version of this document or the latest information.

©DSM Nutritional Products Ltd., 2019 Product Code: 5015131


Global Regulatory Affairs & Quality Management, Personal Care & Aroma Ingredients Version Date: 01.09.2020
PO Box 2676 Replaces Version: 30.06.2020
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Page 2 of 2
Product Information
CMR Statement

REGU®-FADE
Product Code: 5015131

Article 15 of Regulation (EC) n°1223/2009¹ related to Cosmetic Products prohibits the use of
substances which are classified and listed under Regulation (EC) n°1272/2008¹ in Part 3 of Annex VI
as CMR (Carcinogenic, Mutagenic, Reprotoxic), categories 1A, 1B and 2.

In some cases, the use of CMR classified substances may be allowed if certain conditions are
fulfilled, including the evaluation and approval by the European Scientific Committee for
Consumer Safety (SCCS) and exemption granted by the Commission.

Furthermore, according to Regulation (EC) n°2019/831 of 22 May 2019, called the first annual
“Omnibus Act”, amending Regulation (EC) n°1223/2009¹, CMR classified substances are now and
will also be in future included and listed either in the prohibited substances list (Annex II) or the
restricted/authorized substances lists (Annexes III/IV to VI) to that Regulation.

We hereby confirm that this product does not contain intentionally added substances classified
and listed as CMR either in Annexes II to VI under Regulation (EC) n°1223/2009¹ or in Annex VI
under Regulation (EC) 1272/2008¹.

We finally confirm the compliance with Article 17 of Regulation (EC) n°1223/2009¹ which relates to
the allowance of traces of banned substances under the condition that they are technically
unavoidable in good manufacturing practices and do not cause damage to human health when
applied under normal or reasonably foreseeable conditions of use.

¹ and subsequent amendments

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Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume full
responsibility according to the relevant local regulations. The content of this document is subject to change without further notice unless
otherwise agreed in writing. Please consult your local representative or one of DSM‘s websites at https://nutritionportal.dsm.com for the
latest version of this document or the latest information.

DSM Nutritional Products Ltd., Wurmisweg 576, CH-4303 Kaiseraugst Switzerland NUTRITION • HEALTH • SUSTAINABLE LIVING
© DSM Nutritional Products Ltd., 2021 Version 04: 2021-04-06
Replaces Version 03: 2020-06-30
Page 1 of 1
Product Information

REGU®-FADE

Animal Testing Statement


Article 11 (2) (e) of Regulation (EC) No 1223/2009¹ on cosmetic products requires that cosmetic companies
shall keep information on animal tests readily available, including information on animal tests carried out
on the finished cosmetic product as well as its ingredients.
We hereby confirm that this product and its components have not been the subject of animal tests
prohibited by Regulation (EC) No 1223/2009¹ (Article 18) by or on behalf of our company after 11 March
2009. They are in compliance with the above-mentioned legislation.
The following animal tests have been performed on the product after 11 March 2009 by or on behalf of our
company:

Substance (INCI) Type of test Test Test date Testing purpose Performed
number in (Country)
Resveratrol (CAS Cumulative skin PD12026 13/03/2012 non-cosmetic Japan
501-36-0, DSM irritation legislation in
Product Code Japan
5012880)
Resveratrol (CAS PhotosensitizationPD12026 19/03/2012 non-cosmetic Japan
501-36-0, DSM legislation in
Product Code Japan
5012880)
Resveratrol (CAS PhotosensitizationPD12189 10/09/2012 non-cosmetic Japan
501-36-0, DSM legislation in
Product Code Japan
5012880)

These animal tests were not performed in order to meet the requirements of the European Cosmetic
Regulation but in order to meet regulatory requirements of third countries. The tests were performed on a
product manufactured by a different synthesis route. The present product was not tested on animals.
An update of this statement will be made in the exceptional case that animal tests should be necessary.

¹ and subsequent amendments

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application and use of further processed material containing our product. Solely the producer of the final product has to assume full
responsibility according to the relevant local regulations. The content of this document is subject to change without further notice
unless otherwise agreed in writing. Please consult your local representative or one of DSM‘s websites at https://webshop.dsm.com for
the latest version of this document or the latest information.

© DSM Nutritional Products Ltd., 2015 Product Code: 5015131


Global Regulatory Affairs & Quality Management Personal Care Version Date: 10.12.2015
PO Box 2676 Replaces Version: 28.06.2013
CH-4002 Basel/Switzerland Ref: DM/CFJ
Product Information
EU REACh Statement

REGU®-FADE
Product code: 5015131

DSM Nutritional Products is fully aware of the REACh requirements and timetable.

Hereby, we confirm that all products commercialized by DSM Nutritional Products are compliant
with the EU REACh Regulation (EC 1907/2006)1.

All relevant substances have been registered under REACh either by DSM Nutritional Products
or by the relative supplier, or are exempt from REACh registration. For all relevant substances
in DSM Nutritional Products, an Only Representative (OR) in accordance with Article 8 of EU
REACh Regulation (EC 1907/2006)1 has been appointed.

DSM Nutritional Products also tracks all necessary details of the supply chains to ensure
continuity of supply to the Personal Care Industry in Europe. The REACh status of the individual
substances is listed in the table below:

Substance CAS No. EINECS/ REACH Status


ELINCS No. Registration No.
Resveratrol 501-36-0 none Not available Exempt, below 1
ton

For classified substances imported or manufactured in quantity above 10 tons/year exposure


scenarios are needed (Regulation (EC) 1278/2008). DSM Nutritional Products covers Cosmetics
Europe (COLIPA) uses (PC39) and corresponding risk management summarized in the extended
SDS.

1 and subsequent amendments

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Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume full
responsibility according to the relevant local regulations. The content of this document is subject to change without further notice unless
otherwise agreed in writing. Please consult your local representative or one of DSM‘s websites at https://webshop.dsm.com for the latest
version of this document or the latest information.

DSM Nutritional Products Ltd., Wurmisweg 576, CH-4303 Kaiseraugst Switzerland


© DSM Nutritional Products Ltd., 2019 Version 02: 2019-01-17
Replaces Version 01: 2016-11-11
Page 1 of 1
Product Information

REGU®-FADE

SVHC Statement
The information related to the presence of Substances of Very High Concern (SVHC) is contained in section
3 of the Safety Data Sheet of above mentioned product.
Based on product composition and manufacturing process we confirm that the above mentioned product
does not contain any substance(s) listed on the ECHA web site¹ at more than 0.1%.

¹
- Candidate list of Substances of Very High Concern (SVHC) for authorization as defined in the REACh Regulation (EC) No 1907/2006,
Articles 57 and 59(1). For the current version of the list, please consult: http://echa.europa.eu/web/guest/candidate-list-table

- Authorization list (Annex XIV) as defined in the REACh Regulation (EC) No 1907/2006, Article 58. For the current version of the list,
please consult: https://echa.europa.eu/de/authorisation-list

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Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume full
responsibility according to the relevant local regulations. The content of this document is subject to change without further notice
unless otherwise agreed in writing. Please consult your local representative or one of DSM‘s websites at https://webshop.dsm.com for
the latest version of this document or the latest information.

©DSM Nutritional Products Ltd., 2018 Product Code: 5015131


Global Regulatory Affairs & Quality Management Personal Care Version Date: 05.12.2018
PO Box 2676 Replaces Version: 10.12.2015
CH-4002 Basel/Switzerland Ref: RS/CFJ
Page 1 of 1
Product Inf ormat ion

REGU®-FADE

Proposition 65 Stat ement

DSM Nut rit ional Product s as a gl obal company is f ul l y commit t ed t o ensure t he saf et y of all our
raw mat erial s and product s t o be in compliance wit h gl obal legislat ions.

To t he best of our knowledge, we hereby cert if y t hat our product

REGU®-FADE

is in compliance wit h t he St at e of Cal ifornia law Proposit ion 65 t o Saf e Drinking Wat er and Toxic
Enf orcement Act (April 4t h, 2014) when f ormulat ed up t o t he recommended concent rat ion of 1%
in skin care applicat ions.

This document is gener at ed elect ronically and valid wit hout signat ure.
Disclaimer: The infor mat ion cont ained her ein is t o t he best of our knowledge accur at e. However , we ref use any l iabil it y f or t he
applicat ion and use of f urt her processed mat eri al cont aining our pr oduct . Solel y t he producer of t he f inal product has t o assume
f ull responsibilit y accor ding t o t he relevant local regul at ions. The cont ent of t his document is subj ect t o change wi t hout f urt her
not ice unless ot herw ise agreed in wr it ing. Please consult your local represent at ive or one of DSM‘ s websit es at
ht t ps: / / webshop. dsm. com f or t he lat est version of t his document or t he lat est inf or mat ion.

DSM Nut r it ional Product s Lt d. Product Code: 50 1513 1


Global Qual it y Management OPS/ QM Dat e: 2014-04-14
P. O. Box 2676, CH-4002 Basel , Sw it zerl and Ref : UB
Product Information

REGU® - FADE

Regulatory Status - China


Usability of raw materials for Personal Care Products in China is depending on the listing of raw
materials on IECSC and IECIC inventories or on the notification/registration status of the raw material.
Below table provides the above mentioned status:

Composition Chemical Cosmetic Notes


IECSC listing1 or IECIC listing2 or New banned/restricted
New Chemical Cosmetic Ingredient In finished
CFDA INCI name Chinese notification done registration done cosmetic product3
INCI name (Y/N/E) (Y/N)

Resveratrol 白藜芦醇 Y Y -

Y = Yes N = No E = Exempted

Please note that there is no positive cosmetic ingredient list existing in China except for colorants,
UV filters, preservative, hair dyes and restricted ingredients. This information does not exclude
that Chinese cosmetic authorities may ask for additional information related to the above
mentioned product during the finished cosmetic product registration or notification process.

1
IECSC = Inventory of Existing Chemical Substances in China。
2
IECIC = Inventory of Existing Cosmetic Ingredients in China, June 30, 2014, also called CFDA inventory of cosmetic
ingredients which have been used in China.
3
Refers to Chinese Hygienic Standard for Cosmetics Version 2007

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Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume
full responsibility according to the relevant local regulations. The content of this document is subject to change without further
notice unless otherwise agreed in writing. Please consult your local representative for the latest version of this document or the
latest information.

© DSM Nutritional Products Ltd., 2015 Product Code: 5015131


Global Regulatory Affairs & Quality Management Version date: 10.02.2015
P.O. Box 2676 Replaces version: 01.10.2012
CH – 4002 Basel/Switzerland Ref: EW/JJ/AW/DM
Product Information

REGU®-FADE

Regulatory Status

1
Chemical Cosmetic (Y/N)
Registration status based on the Note: Claims on finished cosmetic
1
Country/region Chemical Inventory listing of individual ingredients in products must comply with
inventory and volume exemption national cosmetic legislation
applying (Y/N/R/E)

Andean No inventory No inventory Y


ASEAN No inventory No inventory Y
Australia AICS R (≤ 10 kg/y) Y (see chemical)
Canada DSL R (≤100 kg/y) Y (see chemical)
NDSL -
ICL -
China IECSC Y see separate statement
Europe EINECS/ELINCS R (≤ 1 t/y) Y
REACH
Japan ENCS (CSCL) E Y
Korea KECI (TCCA) E Y
Mercosur No inventory No inventory Y
Mexico INSQ Inventory is not supported by legal Y
framework
New Zealand NZloC Y Y
Philippines PICCS E Y
Switzerland EINECS/ELINCS R (≤ 1 t/y) Y
Taiwan NECI Y Y
USA TSCA E Y
1
above product can be freely imported and sold as cosmetic ingredient also into further countries as e.g. Algeria, Bahrain, Brunei
Darussalam, Egypt, Morocco, the Russian Federation, Tunisia, Turkey, the United Arab Emirates, as long as the safe use is
warranted and the products do comply with the legal requirements as laid down in the Regulation on Cosmetic Products (EC) No.
1223/2009

Chemical Legislation
Yes (Y): The DSM product contains only substances which are either listed in the respective chemical inventory, have been notified
as new chemical substance by DSM or exempted from the chemical notification (e.g. natural)
No (N): The DSM product contains at least a substance not listed or not notified by DSM or not exempted (not compliant with
respective chemical inventory)
Restricted (R): The DSM product contains at least a substance not listed or not notified by DSM or not exempted from the
respective chemical notification but can be imported in the respective country under volume exemption (e.g. Australia, Canada,
Europe, Switzerland)
Exempted (E): under specific exemption applying to cosmetic ingredients (e.g. US, Japan)

© DSM Nutritional Products Ltd., 2014 Page 1 of 2 Product Code: 5015131


Global Regulatory Affairs Version date: 17.04.2014
PO Box 2676 Replaces version: 25.07.2013
CH-4002 Basel/Switzerland Ref: DM/RS
Product Information

Cosmetic Regulation
Yes (Y): product free for sales as cosmetic ingredient for the application and use level recommended by DSM (see marketing
documentation). If any condition of use exists for the active substance, this must be mentioned.
No (N): product not for sales in the respective country (contain at least a substance not allowed in cosmetic in the respective
country)

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Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume
full responsibility according to the relevant local regulations. The content of this document is subject to change without further
notice unless otherwise agreed in writing. Please consult your local representative or one of DSM‘s websites at
https://webshop.dsm.com for the latest version of this document or the latest information.

© DSM Nutritional Products Ltd., 2014 Page 2 of 2 Product Code: 5015131


Global Regulatory Affairs Version date: 17.04.2014
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CH-4002 Basel/Switzerland Ref: DM/RS
Product Information

REGU®-FADE
(trans-resveratrol)

Summary of Safety Data

This document and DSM safety studies referred therein are proprietary information of DSM
relating to its products only. Safety of non-DSM products cannot be substantiated
therewith.

This Summary of Safety Data refers to trans-resveratrol made from two manufacturing processes, both
achieving a very high purity ≥ 99%, and the safety studies conducted with the original process material
are considered applicable to the new process material.
The Summary of Safety Data supports the topical applications at the recommended use levels of up to 1%,
as indicated in the DSM Product Data Sheet.

External expert evaluations


Toxicological studies of trans-resveratrol have been performed by DSM in support of the food use of DSM
trans-resveratrol and for worker safety purposes. The DSM toxicology package for the food use of trans-
resveratrol has been published (Williams et al., 2009). DSM trans-resveratrol was defined as GRAS by an
expert panel in 2007. Additional studies have been performed in support of the dermal use in skin care
products and in order to meet the requirements of non-European and non-cosmetic Regulation and are
among those summarized below.

Acute oral toxicity


No acute study performed by DSM as it was deemed unnecessary based on available safety data
indicating the rodent acute oral LD50 is greater than 2000 mg/kg body weight.

Skin irritation
DSM / External + Ref. DSM internal Report No. 2500439, dated 7 March 2007
Type Primary skin irritation
Guideline + deviations OECD 404 (2002), Directive 2004/73/EC, B.4. "Acute Toxicity - Skin Irritation/
Corrosion"
GLP Yes
Species / sex One male and two female adult New Zealand White rabbits SPF
Test substance / purity Resveratrol (trans-resveratrol), Batch 6308/RES/5b/P/165/001/005, purity
99.1% w/w (CoA 10 November 2005)
Dosage / concentration Single topical semi-occlusive application of 0.5 g for 4h
Result Dermal exposure to 0.5 g resveratrol was non-irritating in rabbits
Study start date 1 November 2006

© DSM Nutritional Products Ltd., 2015 Product Codes: 50 1513 1


Toxicology & Kinetics Page 1 of 7 Version date: 19.11.2015
PO Box 2676 Replaces Version: new
CH-4002 Basel/Switzerland Reference: DM/JAE/JRP
Product Information

DSM / External + Ref. DSM internal Report No. 00018071, dated 29 March 2013
Type 14-Day Cumulative skin irritation
Guideline + deviations Guide to Marketing and Manufacturing of Cosmetics and Quasi-Drugs, Japan,
2006
GLP Yes
Species / sex 3 male Kbl:NZW rabbits
Test substance / purity Resveratrol (trans-resveratrol), Batch UT10100003, purity 99.8% (CoA 11
March 2011)
Dosage / concentration Topical semi-occlusive at 12.5, 25 and 50 w/w% in a dose volume of 0.5
g/site daily for 4h for 14 days
Result Repeated dermal exposure to 0.5 g resveratrol at concentrations ≥ 50%w/w
was non-irritating in rabbits
Study start date 13 March 2012; performed in Japan

DSM / External + Ref. DSM internal report No. 00007602, dated 13 April 2010
Type Human patch test; primary skin irritation test
Guideline + deviations Patch test technique (Finn/IQ chamber), single application for 24 h (0.04 g
in IQ chamber) to upper forearm; assessment at 48 h
GLP Controlled study not under GLP; blinded study design
Species /strain Human, 25 volunteers
Test substance /purity Resveratrol (trans-resveratrol) as formulation, 1.0% w/w, Batch number
100250-082, and 0.2% w/w, Batch number 100250-100
Dosage / concentration Two formulations containing trans-resveratrol at 1.0% or 0.2% w/w, two
control formulations and isotonic saline control
Result Resveratrol formulations were non-irritating.
Study start date March 2010

DSM / External + Ref. DSM internal report No. 00007602, dated 13 April 2010
Type Human patch test in Japanese subjects; primary skin irritation test
Guideline + deviations Patch test technique (Finn/IQ chamber), single application for 24 h (0.04 g
in IQ chamber) to upper forearm; assessment at 48 h
GLP Controlled study not under GLP; blinded study design
Species /strain Human, 25 volunteers
Test substance /purity Resveratrol (trans-resveratrol) as formulation, 1.0% w/w, Batch number
100250-082, and 0.2% w/w, Batch number 100250-100
Dosage / concentration Two formulations containing trans-resveratrol at 1.0% or 0.2% w/w, two
control formulations and isotonic saline control
Result Resveratrol formulations were non-irritating.
Study start date March 2010

© DSM Nutritional Products Ltd., 2015 Product Codes: 50 1513 1


Toxicology & Kinetics Page 2 of 7 Version date: 19.11.2015
PO Box 2676 Replaces Version: new
CH-4002 Basel/Switzerland Reference: DM/JAE/JRP
Product Information

Acute eye irritation


DSM / External + Ref. DSM internal report no. 2500440, dated 7 March 2007
Type Primary eye irritation study
Guideline + deviations OECD 405 (2002); Directive 2004/73/EC, B.5. "Acute Toxicity - Eye
Irritation/ Corrosion"
GLP Yes
Species /strain Rabbit / New Zealand White
Test substance /purity Resveratrol (trans-resveratrol), Batch 6308/RES/5b/P/165/001/005, purity
99.1% w/w (CoA 10 November 2005)
Dosage / concentration Single dose of 0.1g as powder in left eye
Result Mild erythema and irritation of the sclera were observed after 1, 24, and 48
hours; however, after 72 hours erythema and irritation had subsided.
Therefore, 0.1g trans-resveratrol was deemed a non-irritant to rabbit eyes
Study start date 9 November 2006

Skin sensitization
DSM / External + Ref. DSM internal report No. 2500441, dated 12 March 2007
Type Local lymph node assay (LLNA)
Guideline + deviations OECD 429 (2002)
GLP Yes
Species /strain Adult female mice (CBA/CaOlaHsd)
Test substance /purity Resveratrol (trans-resveratrol), Batch 6308/RES/5b/P/165/001/005, purity
99.1% w/w (CoA 10 November 2005)
Dosage / concentration Topically to the dorsal side of both ear lobes - for three consecutive days -
6.25, 12.5, and 25% trans-resveratrol (dissolved in DMF)
Result Compared to stimulation index (SI) ≥ 3 as the threshold for a positive
response, trans-resveratrol showed SI values of 1.49, 1.87 and 1.10.
Resveratrol was non-allergenic (non-sensitizing).
Study start date 17 October 2006

DSM / External + Ref. DSM internal report Nos. 00018072 and 00018073, both dated 29 March 2013
Type Skin Photosensitization in the guinea pig, adjuvant and strip method
Guideline + deviations Guide to Marketing and Manufacturing of Cosmetics and Quasi-Drugs, Japan,
2006
GLP Yes
Species /strain Guinea pig (Slc:Hartley, SPF)
Test substance /purity Resveratrol (trans-resveratrol), Batch UT10100003, purity 99.8% (CoA 11
March 2011)
Dosage / concentration Concentrations of 1 to 25%, with and without UV irradiation
Result Not photosensitizing
Study start date 19 March 2012 and 10 September 2012; performed in Japan

© DSM Nutritional Products Ltd., 2015 Product Codes: 50 1513 1


Toxicology & Kinetics Page 3 of 7 Version date: 19.11.2015
PO Box 2676 Replaces Version: new
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Product Information

DSM / External + Ref. DSM internal report No. 00018074, dated 13 June 2013
Type Human Repeat Insult Patch Test (HRIPT)
Guideline + deviations Standard protocol, exclusive design (only specified formulations tested)
GLP Study performed according to Good Clinical Practice
Species /strain Human
Test substance /purity Resveratrol (trans-resveratrol), as formulation and in Vaseline
Product code 5012880, Batch UQ10433005, purity 100% (CoA 4 May 2012); as
1% formulation, Batch SK-E-101044-2
Product code 5015131, Batch C10080612, purity 101% (CoA 13 August 2012);
as 1% formulation, Batch SK-E-101044-3
Dosage / concentration 1% in formulation, 2% in Vaseline (petrolatum)
Result Resveratrol was non-allergenic (non-sensitizing).
Study start date 06 May 2013

Phototoxicity
DSM / External + Ref. DSM internal report No. 2000901, dated 22 January 2009
Type In vitro 3T3 NRU phototoxicity test
Guideline + deviations OECD 432
GLP Yes
Species /strain BALB/C 3T3 cells, clone 31
Test substance / Batch Resveratrol (trans-resveratrol), Batch 6308/RES/5b/P/165/001/005, purity
99.1% w/w (CoA 10 November 2005)
Concentration Final concentrations of up to 1% in Earle’s Balanced Salt Solution
Metabolic activation Not applicable
Result Resveratrol did not have any phototoxic effects on BALB/c 3T3 cells
Study start date 9 December 2008

Genotoxicity

DSM / External + Ref. DSM internal report No. 2500330, dated 15 September 2006
Type Bacterial reverse mutation assay ("Ames test")
Guideline + deviations OECD 471
GLP Yes
Species /strain S. typhimurium TA1535, TA1537, TA98, and TA 100 and Escherichia coli
WPZ uvrA (pkM101)
Test substance / Batch Resveratrol (trans-resveratrol), Batch 6308/RES/5b/P/165/001/005, purity
99.1% w/w (CoA 10 November 2005)
Concentration up to 5000 μg/plate
Metabolic activation With and without
Result Non mutagenic
Study start date 15 March 2006

© DSM Nutritional Products Ltd., 2015 Product Codes: 50 1513 1


Toxicology & Kinetics Page 4 of 7 Version date: 19.11.2015
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Product Information

DSM / External + Ref. DSM internal report No. 00015115, dated 28 September 2012
Type Bacterial reverse mutation assay ("Ames test")
Guideline + deviations OECD 471
GLP Yes
Species /strain S. typhimurium
TA1535, TA1537, TA98, TA 100 and TA 102
Test substance / Batch Resveratrol (trans-resveratrol)
Product code 5012880, Batch RC09070008, purity 99.6% w/w (CoA 27
January 2012)
Product code 5015131, Batch Z4089: spiked with by-products at 0.2%, end
purity 98.4% w/w (CoA 28 February 2012); Batch S4112, purity 99.4% w/w
(CoA 13 March 2012)
Concentration up to 5000 μg/plate
Metabolic activation With and without
Result Non mutagenic
Study start date 17 April 2012

DSM / External + Ref. DSM internal report, RDR No. 2000902, dated 26 March 2009
Type Photo-mutagenicity, Bacterial reverse mutation assay, ("Ames test")
Guideline + deviations Based on OECD 471 and SCC Guideline CSC/803-5/90
GLP Yes
Species /strain S. typhimurium
TA1537, TA98, TA 100 and TA102
Test substance / Batch Resveratrol (trans-resveratrol), Batch 6308/RES/5b/P/165/001/005, purity
99.1% w/w (CoA 10 November 2005)
Concentrations Up to 5000 µg/plate
Metabolic activation Without (standard for photo Ames)
Result Not photo mutagenic
Study start date 15 December 2008

DSM / External + Ref. DSM internal report no. 2500331, dated 11 July 2006
Type In vitro mammalian chromosome aberration test
Guideline + deviations OECD 437
GLP Yes
Species /strain Human lymphocytes
Test substance / Batch Resveratrol (trans-resveratrol), Batch 6308/RES/5b/P/165/001/005, purity
99.1% w/w (CoA 10 November 2005)
Concentration 5, 10, 20 and 30 μg/ml without metabolic activation and 5, 30, 40 and 50
μg/ml with metabolic activation
Metabolic activation With and without S9 mix
Result Positive result but with No Observed Effect Levels of 5 μg/ml in the absence
of S9 mix and 30 μg/ml in presence of S9 mix
Study start date 7 April 2006

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DSM / External + Ref. DSM internal report 2500332, dated 25 May 2007
Type In vivo mammalian erythrocyte micronucleus test
Method OECD 474 (1997)
GLP Yes
Species / strain Rat / Sprague-Dawley CD
Test substance / Batch Resveratrol (trans-resveratrol), Batch 6308/RES/5b/P/165/001/005, purity
99.1% w/w (CoA 10 November 2005)
Dosage / concentration Orally at 500, 1000 or 2000 mg/kg bw/day for two consecutive days
Result Non-genotoxic at up to 2000 mg/kg bw/day
Study start date 19 June 2006

Sub-acute oral toxicity


DSM / External + Ref. DSM internal Report no, 2500057, dated 18 May 2005
Type Sub-acute rodent study, 28-days
Guideline + deviations OECD 407 (1995)
GLP No
Species / strain Rat / Wistar
Test substance / Batch Resveratrol (trans-resveratrol), 6308/RES/05/M/06/514/001 purity 98.5% w/w
(CoA 3 June 2004)
Dosage / concentration Orally in feed to achieve 0, 50, 150, or 500 mg/kg bw/day
Result NOAEL: 500 mg/kg bw/day (highest dose used)
Study start date 10 September 2004

Sub-chronic oral toxicity


DSM / External + Ref. DSM internal report no. 2500211, 5 April 2007
Type Sub-chronic rodent study, 90-days in feed
Guideline + deviations OECD 408 (1998)
GLP Yes
Test substance / Batch Resveratrol (trans-resveratrol), Batch 6308/RES/5b/P/165/001/005, purity
99.1% w/w (CoA 10 November 2005)
Species / strain Rat / Wistar
Dosage / concentration Orally in feed to achieve 0, 120, 300, or 750 mg/kg bw/day
Result Non-significant decreases in body weight and feed intake were observed in
male rats at 750 mg/kg bw/day and in female rats at 300 and 750 mg/kg
bw/day. No clinical pathology or histological effects of treatment were
observed. The No Observed Adverse Effect Level (NOAEL) was defined as the
high dose of 750 mg/kg bw/day (700 mg/kg bw/day when adjusted for
achieved intake)
Study start date 25 November 2005

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Developmental toxicity

DSM / External + Ref. DSM internal report no. 2500210, dated 21 March 2007
Type Dietary embryo-fetal toxicity
Guideline + deviations OECD 414, CFSAN Red Book (2000)
GLP Yes
Test substance /purity Resveratrol (trans-resveratrol), Batch 6308/RES/5b/P/165/001/005, purity
99.1% w/w (CoA 10 November 2005)
Species / strain/ sex Rat / Sprague-Dawley, female (pregnant)
Dosage / concentration 0, 120, 300, or 750 mg/kg bw/day, orally (in feed) from Day 5 of gestation
through to Day 20 (throughout the organogenesis and fetal development
periods)
Result Body weight gain was significantly reduced up to gestational Day 15 in rats
exposed to 300 and 750 mg/kg bw/day, but it was associated with reduced
food intake. There were no fetal effects considered as treatment-related. The
high dose of 750 mg/kg/day was defined as the NOAEL for maternal toxicity
and as a No Observed Effect Level (NOEL) for the fetus
Study start date 27 February 2006

References
Williams LD, Burdock GA, Edwards JA, Beck M, Bausch J (2009) Safety studies conducted on high-purity
trans-resveratrol in experimental animals, Food Chem Toxicol 47(9):2170-2182.

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Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume
full responsibility according to the relevant local regulations. The content of this document is subject to change without further
notice unless otherwise agreed in writing. Please consult your local representative or one of DSM‘s websites at
https://webshop.dsm.com for the latest version of this document or the latest information.

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Product Information
Packaging Materials

Confirmation

We hereby confirm that all of the primary packaging materials used for the products
marketed by DSM Nutritional Products Ltd comply with the current legislation on materials
and articles intended to come into contact with food, namely:

 European Parliament and Council Directive 94/62/EC of 20 December 19941


 European Parliament and Council Regulation (EC) 1935/20041,
 Commission Regulation (EC) 2023/20061 and
 Commission Regulation (EU) 10/20111 for the EU,

and the Federal Food, Drug and Cosmetic Act of the United States of America (among others
articles; 21 CFR 174 – 178 and 186).

The primary packaging material chosen assures compliance with the products’ specifications
during the specified maximum shelf life when stored under the conditions recommended.

The secondary and further packaging is suitable for mechanical protection, store,
transportation, customer and handling requirements.

We trust these assurances address your concerns. Should you have any further questions,
please contact our local agent.

This document is valid without signature.


Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume
full responsibility according to the relevant local regulations. The content of this document is subject to change without further
notice unless otherwise agreed in writing. Please consult your local representative or one of DSM‘s websites at
https://nutritionportal.dsm.com for the latest version of this document or the latest information.

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Traceability of Packaging Materials

Compliance with Regulation (EC) 1935/2004 on materials and articles


intended to come into contact with food

This legislations extends the traceability for ingredients used in the food chain (EU Food
Framework Regulation (EC) 178/2002, article 18) to all materials and articles coming into
contact with them at all stages of the production and transport in the chain. This
requirement included packaging materials.

In the context of the above mentioned legislation and specifically of article 17 on the
traceability of the packaging traceability means “the identification of the business from
which and to which materials or articles are supplied”. The traceability must be facilitated
by an appropriate system of documentation or information.

DSM Nutritional Products Ltd has a system and procedures in place to allow full traceability
of materials and articles coming in contact with the food or food ingredient and therefore
is in compliance with the EU Regulation (EC) 1935/2004, specifically with article 17 on the
traceability of packaging.

We trust these assurances address your concerns. Should you have any further questions,
please contact our local agent.

This document is valid without signature.


Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume
full responsibility according to the relevant local regulations. The content of this document is subject to change without further
notice unless otherwise agreed in writing. Please consult your local representative or one of DSM‘s websites at
https://nutritionportal.dsm.com for the latest version of this document or the latest information.

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Product Information
Sustainability Throughout the Food Chain

Introduction

DSM is a global supplier of life science products and performance materials. DSM defines
sustainability as follows:

‘Meeting the needs of the present generation without compromising the ability of future
generations to meet their own needs.’

Sustainability is currently one of the DSM’s fundamental business drivers in all our
markets. In addition, it is the fundament of our 3 core principles for DSM behavior with
regards to valuable partnership, respect for people and good corporate citizenship.
Sustainability is driving our Triple-P concept, around:

- People+: Improving people’s life through DSM activities and innovation;


- ECO+: Improving environmental impact of DSM activities and products;
- Profit+: creating profitable businesses, whilst meeting DSM People + and ECO+
objectives to provide solutions on global society needs.

Our belief in sustainability as our core value, key responsibility and important business
driver is reflected in the recognition we receive in Environmental, Social, Governance (ESG)
ratings and benchmarks:
- In June 2019, the investment research firm MSCI has upgraded DSM from an AA
position to AAA. This improved ranking is due to a strong overall ESG performance
across DSM’s businesses as well a lowered risk profile based on DSM’s business
portfolio.
- In May 2018 DSM was assessed as an ESG leader within the chemicals industry by
Sustainalytics, ranking number 1 out of 135 companies.
- In November 2018 DSM was again awarded a Gold CSR Rating by Ecovadis. Our score of
75 points puts us in the top 1% of companies assessed on the platform in our industry.
- In 2018 the Carbon Disclosure Project (CDP) assessed our climate strategy and water
governance and strategy as A- for Climate Change and B- for Water Security.
- In July 2019, DSM was again confirmed as constituent of the FTSE4Good index. We have
held a position on this list since 2004.
DSM is a constituent of the Vigeo Eiris Benelux 20, Europe 120, Eurozone 120 and World 120

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Sustainability Throughout the Food Chain

indices, based on the review performed in October 2017.

People+

The People+ concept in our production means that DSM strives for a safe working
environment for its employees, with a very ambitious target of zero accidents on sites.
This is to be achieved by 1) a fundamental culture change management leading to better
understanding of our processes and their risks, 2) a better implementation of risk
reducing measures at individual level, and 3) increased people training and awareness
building in the work environment.

In addition, one of DSM’s objectives is to improve people’s life through innovation. To


do so, DSM is developing metrics to evaluate progress in people’s life and participate
to global activities to reduce malnutrition (one of the key Millennium objectives).

ECO+

The objective of the ECO+ activities within DSM is to reduce the environmental footprint of
the company’s production systems. In addition, we aim to reduce the environmental
footprint of our customers when using our products. We therefore compare our products
and solutions with competitive solutions in the same market and place priorities on
solutions and products, which provide our customers with the lowest environmental
footprint.

To achieve these objectives, DSM has developed internal structure and process to:

- Improve its manufacturing processes through innovation by e.g.:

o Developing the use of renewable resources, when possible, to produce


our products (e.g. through white biotechnology1)
o Reducing the use of energy and water in our processes

1White Biotechnology is the use of living microorganisms to develop or make useful products. White Biotechnology tends to
consume less in resources than traditional processes used to produce industrial goods (www.europabio.org)

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Sustainability Throughout the Food Chain

- Innovate in new products linked to:

o The reduction of emission from livestock production on farm2


o The reduction of energy consumption for producing food
o The reduction of food waste

- Source our raw materials from sustainable food chain:

o Produce omega-3 and Omega-6 fatty acids from natural sustainable sources3
o Utilizing optimally the natural sources produced in a sustainable way4

Sustainable supply of Omega-3 and Omega-6 fatty acids

Omega-3 and Omega-6 fatty acids are essential nutrients for people
Omega-3 and Omega-6 fatty acids are well spread in nature and they are mainly
present in fatty fish, plants, and fungi.

DSM Nutritional Products is committed to provide sustainable source of Omega-3 and


Omega-6 fatty acids from the different natural sources available on our planet.

When producing Omega-3 fatty acids (our MEG-3® product range) from aquatic sources
(fish), DSM Nutritional Products is committed to the responsible and sustainable use of
natural marine sources that promote marine biodiversity and will help to safeguard our
marine environments and fish stocks for future generations. Therefore, DSM Nutritional
Products sources fish-derived omega-3 fatty acids from qualified fisheries. DSM MEG-3
fish oil products has achieved Friend of the Sea certification. With a view to further
promoting sustainable fishing practices, DSM Nutritional Products has built strong
relationship with government agencies and major Peruvian producers5.

2 For more details, see our document: Innovation for sustainable animal production
3 For more details, see our document: Sustainable Omega-3 and Omega-6 production
4 For more details, see our document: Sustainable Palm Oil
5 The Peruvian government is recognized worldwide for its control and regulation of the fishing Industry. Peruvian water is

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Sustainability Throughout the Food Chain

DSM Nutritional Products has innovated in biotechnology during the last decades and has
acquired knowledge and production facilities to develop the production of Omega-3 and
Omega-6 fatty acids from algae and fungi (our life’s™ product range). Algae and fungi
production enables the use of renewable materials, used for growing the algae and the
fungi in fermenters. In addition, DSM Nutritional Products has developed natural
concentration processes to provide ready to use Omega-3 and Omega-6 fatty acids.

Sustainable use of palm oil and derivatives

DSM Nutritional Products provides product forms and preparations enabling the proper
and efficient use of the active substances in customers’ products. This creates, for example,
an increased stability of the active substances during storage and processing or an
improved bioavailability for the end consumer.

Based on its experience and expertise, DSM Nutritional Products develops the best in
class forms for the specific local markets. The use of palm oil in certain formulations
provides benefits for the proper handling and use of our products by our customers.
Furthermore, the application of our products only adds very low amounts of palm oil in
our consumer’s products, such as food as consumed.

Nevertheless, in line with DSM’s sustainable approach of food products, DSM Nutritional
Products limits the use of palm oil to product forms, in which it provides significant
benefits in the application. We secure the sourcing of palm oil from sustainable sources,
considering the environmental and social impact of palm oil production, particularly:

- DSM Nutritional Products sources only palm oil from companies proving
adherence to the RSPO6 mission, i.e.:

o To advance the production, procurement, finance and use of

continually monitored by the Marine Institute of Peru (IMARPE) to ensure sustainability.


6 RSPO = Roundtable on sustainable palm oil (www.rspo.org)

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Sustainability Throughout the Food Chain

sustainable palm oil products;


o To develop, implement, verify, assure, and periodically review credible
global standards for the entire supply chain of sustainable palm oil;
o To monitor and evaluate the economic, environmental, and social impacts
of the uptake of sustainable palm oil in the market;
o To engage and commit all stakeholders throughout the supply
chain, including governments and consumers.

- DSM Nutritional Products manufacturing sites have been certified as compliant


with the RSPO Supply Chain Certification Standard, implementing the
«Segregation» and «Mass Balance» approaches. This certification covers all
sites producing formulations containing palm oil and derivatives.

DSM Nutritional Products is committed to further secure the sustainable sourcing of palm
oil. The above- mentioned certificate is valid until 3 June 2025.

Innovation in animal nutrition

Livestock production is one of the main contributors of emissions, which may have a
detrimental effect on the environment within the food chain. Depending on the
production systems and farm management, including feeding and nutrition management,
the impact on the environment varies (different level and type of impacts).

DSM Nutritional Products is active in the field of animal nutrition since more than a
century and has developed products that provide:

- Micronutrients for better livestock production and welfare and


- Feed ingredients supporting animal performance through proper feed digestion
and/or better animal metabolism.

Scientists and policy makers has now recognized the benefit of performance
improvement as one of the key elements to reduce the environmental footprint of

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Sustainability Throughout the Food Chain

livestock product, within a given production system. Indeed, the improvement of animal
performance leads to:

- Improved feed efficiency (i.e. less raw materials used for the same production of
meat, milk, or eggs);
- Decreased numbers of animals needed for achieving the same farm production
(e.g., by reducing the mortality or morbidity, linked to improved animal welfare;
improved fertility and animal’s longevity)
- Increased animal metabolism, though micronutrition (i.e., increase the
performance of the natural metabolic use of the nutrients from the diet)

Over the last decade, DSM Nutritional Products has developed the use of solutions that
cover the three above mentioned elements, with a view to improve the sustainability of
livestock production, reducing the environmental footprint and providing economic
benefits to the food chain. Ourenzymes (RONOZYME® HiPhos and ProAct), benzoic acid
(VevoVitall®) and probiotics (CYLACTIN®) are the most prominent examples of DSM
Nutritional Products contribution to sustainable livestock production.

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Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume
full responsibility according to the relevant local regulations. The content of this document is subject to change without further
notice unless otherwise agreed in writing. Please consult your local representative or one of DSM‘s websites at
https://nutritionportal.dsm.com for the latest version of this document or the latest information.

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Product Information
Lot Code Explanation (General)

Lot numbers for the products of DSM Nutritional Products do not translate directly into a
date of production. The date (month and year) is printed on each carton label and mentioned
on the “Certificate for Customer” which accompanies each shipment of material.

Lot numbers are assigned at each manufacturing facility in accordance with current site
Standard Operating Procedures. The first two digits designate the site of manufacture and the
rest relate to batch number identification. These lot codes can be tracked internally to
specific batch records for the sake of traceability.

Thank you for your continued business with DSM Nutritional Products.
We trust these assurances address your concerns. Should you have further questions please
contact our local agent.

This document is valid without signature.


Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume
full responsibility according to the relevant local regulations. The content of this document is subject to change without further
notice unless otherwise agreed in writing. Please consult your local representative or one of DSM‘s websites at
https://nutritionportal.dsm.com for the latest version of this document or the latest information.

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Product Information
Glossary

Glossary

Abbreviations
BSE/TSE: Bovine Spongiform Encephalopathy/Transmissible Spongiform Encephalopathy
CITES: the Convention on International Trade in Endangered Species of Wild Fauna and Flora
COSING: the database of the European Commission on cosmetic substances and ingredients
CMR: Carcinogenic, Mutagenic, or Toxic for Reproduction
GHS: Globally Harmonized System (of classification and labelling)
GMO: Genetically Modified Organism
GMP: Good Manufacturing Practice
Nano: Nanomaterial
PAHs: Polycyclic Aromatic Hydrocarbons
PBT/vPvB: Persistent, Bioaccumulative and Toxic/very Persistent and very Bioaccumulative
(according to Regulation (EC) No 1907/2006)
PCB: PolyChlorinated Biphenyl
REACh: Registration, Evaluation, Authorisation and Restriction of Chemicals (according to
Regulation (EC) No 1907/2006)
SCCNFP: Scientific Committee on Cosmetic Products and Non-Food Products intended for
Consumers
SCCS: Scientific Committee on Consumer Safety
SVHC: Substance of Very High Concern (according to Regulation (EC) No 1907/2006)
VOC: Volatile Organic Compound

Definition of terms
Ingredient: substance intentionally added to the DSM sales product and having a function in

the sales product Substance: means a chemical entity

Not expected and not determined: based on our current knowledge of the production
process, raw material(s) and/or equipment used for the manufacture of the product, the
substance(s) is/are not expected to be present and consequently no measurement was
performed.

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Glossary

Not applicable: the item is not relevant and therefore does not apply to the product (e.g. a
CITES certificate for a synthetic product is not relevant).

Definition of criteria

1. Source of ingredient(s)

The information on the source of ingredients is based on DSM`s internal knowledge or


information provided by suppliers. One or more sources may apply to an ingredient (listed by
its INCI name). In this case the last sourcing step is indicated (e.g. “fermentation of a sugar
from plant” - the source is “Biotechnology”).

Synthetic: ingredients which contain hydrocarbons or which are derived from coal or crude
oil (see also petroleum derived) and/or ingredients which are made by a chemical reaction of
one or several educts to form a new chemical entity.
Biotechnology: ingredients made from or with microorganisms (e.g. fermentation, hydrolysis
by enzymes isolated from bacteria).
Vegetable: ingredients derived from plants in the sense of “botanical ingredients” (for
comparison: ingredients derived from sugar(s) from plants and used for fermentation are not
“botanical ingredients”). Fungi derived ingredients are included here despite fungi represent
an own taxonomic group.
Animal: ingredients produced by animals (e.g. milk lipids, silk) or derived from animal tissues
(e.g. collagen).
Mineral: ingredient(s) from an inorganic source (substances without hydrocarbons)
Petroleum derived: ingredients derived from coal, unprocessed or refined crude oil.
Significant petrochemicals are olefins (including ethylene and propylene) and aromatics
(including benzene, toluene and xylene isomers) and their derivatives, e.g. phenoxyethanol,
propylene glycol, methylparaben, benzoic acid.

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Glossary

2. Function of Ingredient(s)

The functions of the ingredients are indicated as reported in cosmetic ingredient databases,
such as CosIng.

Ingredients listed in Annexes (II, III, IV, V, VI) of Cosmetic Regulation (EC) 1223/2009: the given
concentration represents the concentration in the product (not the max. allowed
concentration).

3. Substance(s) potentially contained

Food allergens
Cereals containing gluten and products thereof: refers to materials such as wheat, rye,
barley, oats, spelt, kamut or their hybridized strains and/or products thereof (according to
Regulation (EU) No 1169/2011).

Nuts and nut products (incl. peanuts): refers to almonds (Amygdalus communis L.), hazelnuts
(Corylus avellana), walnuts (Juglans regia), cashews (Anacardium occidentale), pecan nuts
(Carya illinoiesis (Wangenh.) K. Koch), brazil nuts (Bertholletia excelsa), pistachio nuts
(Pistacia vera), macadamia nuts or Queensland nuts (Macadamia ternifolia), peanut, beech
nut, butter nut, chestnut, chinquapin, hickory nut, lichee nut, pine nut, pili nut, sheanut and
products thereof (referring to EU and US Food Regulation).
Other various substances
Formaldehyde and formaldehyde releasers: refers to formaldehyde and formaldehyde
releasers as mentioned in the SCCNFP Opinion on the Determination of Certain Formaldehyde
Releasers in Cosmetic Products, 17 December 2002: Quaternium-15, Urea derivatives (e.g.
Imidazolidinyl Urea, Diazolidinyl Urea), DMDM Hydantoin, 2-Bromo-2nitropropane-1,3-diol,
Sodium Hydroxymethyl Glycinate, Benzylhemiformal, 5-Bromo-5-nitro-1,3-dioxane,
Methenamine.

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Phthalates: refers to esters of phthalic acid (e.g. Dimethyl phthalate (DMP), Diethyl phthalate
(DEP), Dibutyl phthalate (DBP), Butyl Benzyl phthalate (BBP), Di(2-ethylhexyl)phthalate
(DEHP), Dimethoxyethyl phthalate (DMEP), Diisopentylphtalate (DIPP), Di-n-pentyl phthalate
(DNPP), Di-n-octyl phthalate (DNOP), n-pentyl-isopentylphtalate (PIPP). The main source of
phthalates are plasticizers used in packaging.

Glycol ethers: refers to ethers of Ethylene Glycol or Diethylene Glycol

Free Amines: refers to primary (monoalkylamines, monoalkanolamines), secondary


(dialkylamines, dialkanolamines) and tertiary (trialkylamines, trialkanolamines) amines (see
SCCS Opinion on Nitrosamines and Secondary Amines in Cosmetic Products, 27 March 2012):

R1, R2, R3 = H or organic group like alkyl, alkanol, alkylamine, aryl, aryl-alkyl

Nitrosamines: refers to the potential presence of nitrosamines based on the production

process and the used substances Monomer residues: refers to synthetic monomers

Dioxin and PCBs: refers to dioxins (PolyChlorinated Dibenzo-p-Dioxins [PCDDs] and


Dibenzofurans [PCDFs]) and PCBs (PolyChlorinated Biphenyls) (according to Regulation (EC)
No 1881/2006)

PAHs: refers to Polycyclic Aromatic Hydrocarbons, such as Benzo-(α)-pyrene, Benzo-(α)-


anthracene, Benzo-(β)fluoranthene and chrysene (according to Regulation (EC) No 1881/2006)

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Glossary

4. Regulatory Information

Last animal testing date: toxicological tests done on animals after March 2009 testing dates
are indicated in the Animal Testing Statement according to (EC) No 1223/2009. For animal
tests done before March 2009 the last testing date is given in the Technical Dossier.

Nano declaration information: refers to e.g. the French annual declaration of substances at
nanoscale (Decree no. 2012-232 of 17 February 2012 in application of article R. 523-4 of the
French environment code) or similar.

Additional Nano information: refers to e.g. particle size distribution information of


nanomaterials.

5. Safety and environment

VOC substance(s) according to positive list of Swiss VOC Regulation contained: means the
substance(s) is/are present according to the definition in Swiss VOC Regulation (Ordinance
814.018 on the Incentive Tax on Volatile Organic Compounds) and more precisely in the
corresponding positive list (Annex I of the Regulation). Ingredients part of our product
composition are only considered (neither impurities nor residual solvents).

6. Product suitability

Kosher/Halal status: The product can be either Kosher and/or Halal compliant - based on
DSM self-assessment (DSM statement) - or certified by a certifying body (Kosher/Halal
certificate).

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8. Quality information

GMP standard states the Good Manufacturing Practice which is applied for this product. The
highest GMP standard applied to the product is given. The product is either certified by a
certifying body or compliant based on DSM selfassessment (audit).

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Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the
application and use of further processed material containing our product. Solely the producer of the final product has to assume
full responsibility according to the relevant local regulations. The content of this document is subject to change without further
notice unless otherwise agreed in writing. Please consult your local representative or one of DSM‘s websites at
https://nutritionportal.dsm.com for the latest version of this document or the latest information.

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