Regu®-Fade - Product Dossier
Regu®-Fade - Product Dossier
Regu®-Fade - Product Dossier
Product Dossier
REGU®-FADE
Product Code: 5015131
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Representative Composition
Manufacturing Principle
Technical dossier
1. Source of ingredient(s)
GMO statement
BSE/TSE statement
Residual solvents
Pesticide statement
4. Regulatory information
Compliance confirmation
CMR statement
SVHC statement
7. Packaging materials
9. Supportive documentation
Sustainability document
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
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'.
REGU®-FADE
Product code: 5015131
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.
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 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
REGU®-FADE
Product Code: 5015131
This statement provides information about the representative product composition for Personal Care
Customers.
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.
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.
REGU®-FADE
Product code: 5015131
1. Appearance: powder
3. Identity corresponds
The identity test is performed by IR.
REGU®-FADE
Product code: 5015131
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
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).
REGU®-FADE
Product code: 5015131
o Dilution factor
1 10 200 50
* * 2.0
100 50 1 10
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
REGU®-FADE
Product Code: 5015131
1. Source of ingredient(s)
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
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
4. Regulatory 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 3 of 7
Product Information
Technical Dossier
REGU®-FADE
Product Code: 5015131
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
6. Product suitability
7. Packaging materials
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
9. Supportive documentation
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
Origin India
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.
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:
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.
REGU®-FADE
Product code: 5015131
• 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
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.
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.
REGU®-FADE
List of potential fragrance allergens as listed in Regulation (EC) 1223/2009 and subsequent
amendments:
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.
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
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.
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:
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
REGU®-FADE
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.
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.
REGU® - FADE
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
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)
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)
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)
REGU®-FADE
(trans-resveratrol)
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.
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 / 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
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 / 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 / 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
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
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.
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:
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 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.
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:
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
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.
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:
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)
o Produce omega-3 and Omega-6 fatty acids from natural sustainable sources3
o Utilizing optimally the natural sources produced in a sustainable way4
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.
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
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.
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.:
DSM Nutritional Products is committed to further secure the sustainable sourcing of palm
oil. The above- mentioned certificate is valid until 3 June 2025.
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:
Scientists and policy makers has now recognized the benefit of performance
improvement as one of the key elements to reduce the environmental footprint of
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.
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.
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
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.
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)
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.
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).
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.
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.
R1, R2, R3 = H or organic group like alkyl, alkanol, alkylamine, aryl, aryl-alkyl
process and the used substances Monomer residues: refers to synthetic monomers
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.
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).
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).