Product Dossier Personal Care · 2019-06-17 · Staphylococcus aureus not detectable in 1 ml Candida albicans not detectable in 1 ml Escherichia coli not detectable in 1 ml This document

©DSM Nutritional Products Ltd., 2019 Product Code: 5033152Compilation Date: 18.01.2019

PO Box 2676 Previous Compilation Date: 09.01.2019CH-4002 Basel/Switzerland

Personal Care

Product Dossier

PENTAVITIN®



Table of ContentsBelow 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 bookmarkbar of your PDF reader. Please note that some chapters of the technical dossier might not be listed in the table of contents. In suchcases, statements belonging to the respective chapter are not available.

Technical Data Sheets

Product Data Sheet

Manufacturing Principle

Specifications & Tests

Technical Dossier

Technical Dossier document

1. Source of ingredient(s)

GMO statement

BSE/TSE statement

3. Substance(s) potentially contained

Heavy metal statement

Residual solvents

Pesticide statement

4. Regulatory information

Compliance statement

Fragrance allergen statement

CMR statement

Animal testing statement

REACh statement

SVHC statement

California Proposition 65 statement

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



China regulatory status

Global regulatory status

5. Safety and environment

Toxicological information statement

6. Product suitability

Ecocert certificate

Natrue certificate

Cosmos certificate

Halal certificate

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

Product InformationProduct Data Sheet

PENTAVITIN®

© DSM Nutritional Products Ltd. 2017PDS 50 3315 2 Version 08 PENTAVITIN® 2017-01-24pds5033152_08_pentavitin.docx Replaces Version 07: 2015-07-10

Page 1 of 3

DescriptionPENTAVITIN® is 100% natural and plant-derived. The Saccharide Isomerate is formed byisomerisation of plant-derived D-glucose and is similar to that of the carbohydrate complexfound in human skin. It is suitable for both skin- and hair care applications.PENTAVITIN® is ECOCERT- and COSMOS approved, as well as NATRUE certified.

Product identificationProduct code: 50 3315 2

Composition

INCI name Content CAS No. EINECS/ELINCSSaccharide Isomerate > 50% 100843-69-4 noneAqua 25-50% 7732-18-5 231-791-2Citric Acid 0.1-1% 77-92-9 201-069-1Sodium Citrate 0.1-1% 68-04-2 200-675-3

The two main components of the Saccharide Isomerate are glucose (CAS No. 50-99-7, EINECSNo. 200-075-1) and fructose (CAS No. 57-48-7, EINECS No. 200-333-3).

SpecificationsAppearance: clear, yellowish to slightly amber coloured, slightly

viscous liquid

pH: 4.0 – 5.0

Residue on drying: 52.0 – 55.0 % m/m

Relative density d20/20: 1.240 - 1.255

Refractive index n25: 1.422 - 1.430

Identity by Infrared spectrum: corresponds to reference spectrum

Total aerobic mesophile plate count: < 100 CFU / ml

Specified microorganisms: not detectable in one milliliter

SolubilityPENTAVITIN® is soluble in water.


PENTAVITIN®


Page 2 of 3

Stability and storagePENTAVITIN® may be stored for at least 36 months from the date of manufacture in theunopened original container protected from light in a clean place and at a temperaturebetween 15 and 25°C. The ‘Best use before’ date is printed on the label. Keep package tightlyclosed. Once opened, use contents quickly. In order to avoid secondary microbialcontamination, following opening, containers should be handled with special care.

UsesPENTAVITIN® is an ingredient for personal care products. PENTAVITIN® can be processed eitherwarm (< 60°C) or cold, and should be incorporated into the aqueous phase of a cosmeticformulation. For skin care preparations, the addition of 1 to 5% PENTAVITIN® is recommendedand for hair applications we recommend 0.2% in shampoo and 0.5% in conditioner/treatments.

CertificationsECOCERT

PENTAVITIN® is approved by Ecocert Greenlife according to the Ecocert Standard for Natural andOrganic Cosmetics available at http://cosmetics.ecocert.com.100% Natural origin, 0% Synthetic origin

COSMOS

PENTAVITIN® is approved by Ecocert Greenlife according to the Cosmos Standard available athttp://cosmos.ecocert.com.100% Natural origin, 67.1% CPAI (Chemically Processed Agro-Ingredient)

NATRUE

PENTAVITIN® complies with the NATRUE criteria2% Natural (0% Organic), 48% Water, 50% Derived Natural, 0% Nature-identical

SafetyThis product is safe for the intended use. Avoid ingestion or direct contact by applying suitableprotective measures and personal hygiene.

For full safety information and necessary precautions, please refer to the respective DSMMaterial Safety Data Sheet.

Legal noticeThe information given in this publication is based on our current knowledge and experience, andmay be used at your discretion and risk. It does not relieve you from carrying out your ownprecautions and tests. We do not assume any liability in connection with your product or its use.You must comply with all applicable laws and regulations, and observe all third party rights.


PENTAVITIN®


Page 3 of 3

Additional informationTo find out more about our ingredients, please contact your nearest DSM Nutritional Productsoffice.

DSM Nutritional Products LtdProduct ManagementBuilding 241PO Box 2676CH-4002 BaselSwitzerland

Tel.: +41 (0) 61 815 8899Internet www.dsmnutritionalproducts.com

DSM Nutritional Products LLC45 Waterview BoulevardParsippany, NJ 07054-1298

Tel.: +1 (800) 526 0189 (Human Nutrition, Personal Care)Tel.: +1 (800) 451-8325 (Animal Nutrition)Internet www.unlimitednutrition-na.dsm.com

DSM Nutritional Products Europe Ltd.PO Box 2676CH-4002 BaselSwitzerland

Tel.: +41 (0) 61 815 7777Internet www.unlimitednutrition-eu.dsm.com

DSM Singapore Industrial Pte Ltd.trading as DSM Nutritional Products Asia Pacific30 Pasir Panjang Road #13-31Mapletree Business CitySingapore 117440

Tel.: + (65) 66326500Internet www.dsmnutritionalproducts.com

DSM Nutritional Products ChinaNo. 476, Li Bing RoadZhangjiang High-Tech ParkPudong Area, Shanghai 201203P.R. of China

Tel.: + 86 (0)21 6141 8188Internet www.dsmnutritionalproducts.cn

DSM Produtos Nutricionais Brasil S.A.Avenida Engenheiro Billings, nº 1729 – Prédio 31Sala ACEP:05321-010São Paulo – SPBrasil

Tel.: + 55 (11) 3760-6300Internet www.dsmnutritionalproducts.com

Product Information

PENTAVITIN® Manufacturing Principle

DSM Nutritional Products Ltd.

Global Quality Management OPS/QM

P.O.Box 2676, CH-4002 Basel, Switzerland

Product Code: 50 3315 2 Version 02: 2011-06-14

Replaces version 01: 2011-02-02 Ref: KO/PR Page 1 of 1

Carbohydrate mixture is dissolved in water. The pH is adjusted and the solution is isomerized by heating. The isomerized carbohydrate solution is purified by chromatography. The purified fraction is formulated, controlled and conditioned. Then the final solution is filtered and filled into containers.


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.

Product Information

PENTAVITIN®

Specification and Tests

© DSM Nutritional Products Ltd. 2016

Global Regulatory Affairs and Quality Management


Page 1 of 2

Product Code: 50 3315 2Version 03: 2016-12-09

Replaces version 02: 2011-06-07Ref: AG/FC

1. Appearance: Clear, yellowish to slightly ambercoloured, slightly viscous liquid

According to a visual inspection

2. pH: 4.0 – 5.0

According to EP 2.2.3

3. Residue on drying: 52.0 – 55.0% m/m

According to EP 2.2.32, method d), 105°C, 4h, sample amount = 0.5 g

4. Relative density d20/20: 1.240 – 1.255


5. Refractive index n25: 1.422 – 1.430


Product Information

PENTAVITIN®

Specification and Tests

© DSM Nutritional Products Ltd. 2016

Global Regulatory Affairs and Quality Management


Page 2 of 2

Product Code: 50 3315 2Version 03: 2016-12-09

Replaces version 02: 2011-06-07Ref: AG/FC

6. Identity by Infrared spectrum: corresponds to reference spectrum


7. Total aerobic mesophile plate count: < 100 CFU / ml


8. Specified microorganisms:

Referring to EP 2.6.13 and to Cosmetics Europe, “Guideline on Microbial QualityManagement”

Pseudomonas aeruginosa not detectable in 1 ml

Staphylococcus aureus not detectable in 1 ml

Candida albicans not detectable in 1 ml

Escherichia coli not detectable in 1 ml


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

Technical DossierPersonal CareProduct: 5033152 PENTAVITIN®Origin: Aesch (Switzerland)

©DSM Nutritional Products Ltd., 2019 Product Code: 5033152Personal Care Version Date: 09.01.2019PO Box 2676 Replaces Version: 27.07.2018CH-4002 Basel/Switzerland Ref: KOS/DM

Page 1 of 6


Source of active ingredient(s) Yes No Comments

Synthetic X

Biotechnology X

Vegetable X Saccharide Isomerate (derived from dextrosemonohydrate from maize kernels)

Animal X

Mineral X

Source of formulation ingredient(s) Yes No Comments

Synthetic X

Biotechnology X Citric Acid (fermentation), Sodium Citrate(fermentation)

Vegetable X

Animal X

Mineral X Aqua

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

Ionisation/Irradiation Yes No Comments

Ionisation or irradiation applied to this product X



Page 2 of 6

2. Function of the ingredient(s)

Function Yes No Comments

Active substance(s) X Saccharide Isomerate (skin conditioning agent,humectant)

Solvent(s) / carrier(s) X Aqua

Antioxidant(s) X

Ingredient(s) listed in Annexes (II, III, IV, V, VI) ofCosmetic Regulation (EC) 1223/2009

X

Others X Citric Acid, Sodium Citrate


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

Other various substances Yes No Comments

Ethanol and denatured alcohol X Not expected and not determined

Formaldehyde and formaldehyde releasers X Formaldehyde max. 10 ppm

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 Not expected and not determined

Nitrosamines X Not expected and not determined

Acrylamide X Not expected and not determined

Monomer residues X Not expected and not determined

Dioxin/PCB X Not expected and not determined



Page 3 of 6

Other various substances Yes No Comments

PAH(s) X Not expected and not determined

Heavy metals statement available X

Residual solvents statement available X

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 Photosensitization, phototoxicity guinea pig, 1995

Last animal testing date for non-cosmetic purpose X Acute eye irritation rabbit, 1995 (worker safety)

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



Page 4 of 6

US legislation Yes No Comments

Californian Proposition 65 statement available X

China legislation Yes No Comments

China regulatory status statement available X

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 nanomaterial 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 NagoyaProtocol (October 2014)


Toxicology Yes No Comments

Toxicological information statement available X

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



Page 5 of 6

Volatile organic compound(s) Yes No Comments

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

X


Eco certification Yes No Comments

Ecocert certificate available X

Natrue certificate available X

Cosmos certificate available X

Fair Trade certificate available Not applicable

Kosher / Halal status Yes No Comments

Kosher certificate/statement available X Not assessed

Halal certificate/statement available X

7. Packaging materials

Packaging compliance Yes No Comments

Traceability of packaging materials statementavailable

X

Compliance of packaging materials statementavailable

X

Treatment of pallets statement available X The pallets are heat-treated according to IPPCStandard ISPM-15.

8. Quality information

Quality standards Yes No Comments

GMP standard applied for this product X EFfCI GMP (2017) certified



Disclaimer: The information contained herein is to the best of our knowledge accurate. However, we refuse any liability for the application anduse of further processed material containing our product. Solely the producer of the final product has to assume full responsibility accordingto 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 thelatest information.


Page 6 of 6

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

10. Additional information

Technical Dossier Yes No Comments

Glossary Technical Dossier available X

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

PENTAVITIN®

GMO Statement

We hereby confirm that the product PENTAVITIN® is manufactured by conventional processes** andtherefore does not contain GMO-DNA.

Product Information

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 theapplication and use of further processed material containing our product. Solely the producer of the final product has to assume fullresponsibility according to the relevant local regulations. The content of this document is subject to change without further notice unlessotherwise agreed in writing. Please consult your local representative or one of DSM's websites at http://webshop.dsm.com for latestversion of this document or the latest information.

DSM Nutritional Products Ltd. Product Code: 50 3315 2Global Quality Management Page 1 of 1 Date: 2011-05-27P.O. Box 2676, CH-4002 Basel, Switzerland Reference: KCl/FC

PENTAVITIN®

BSE / TSE Statement

We hereby confirm that the manufacturing process of this product does not include the use of materials ofanimal or human origin.

Product Information

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 theapplication and use of further processed material containing our product. Solely the producer of the final product has to assume fullresponsibility according to the relevant local regulations. The content of this document is subject to change without further notice unlessotherwise agreed in writing. Please consult your local representative or one of DSM's websites at http://webshop.dsm.com for latestversion of this document or the latest information.

DSM Nutritional Products Ltd. Product Code: 50 3315 2Global Regulatory Affairs Page 1 of 1 Date: 2013-Sep-10P.O. Box 2676, CH-4002 Basel, Switzerland Reference: AGG/THB

Product Information

PENTAVITIN®

To Whom it May Concern Heavy Metals Statement





Replaces Version 04: 2013-04-30 Ref: KO/FC Page 1 of 1



We hereby state that there are appropriate procedures in place to control heavy metals

contamination.

The following specifications are met:

Metals as lead (1) max. 10 ppm

Arsenic (2) max. 1.0 ppm

Lead (2) max. 1.0 ppm

Mercury (2) max. 0.1 ppm

Cadmium (2) max. 0.5 ppm

Nickel (2) max. 2.0 ppm

Antimony (2) max. 2.0 ppm

Copper (2) max. 10 ppm

Chrome (2) max. 10 ppm

The procedures are based on relevant Quality and/or Good Manufacturing Practice (GMP)

standards. (1)

: according to EP 2.4.8 (2)

: according to EP 2.2.23

Product Information

PENTAVITIN® Residual Solvent Statement





Replaces version 01: 2010-10-28 Ref: KO/PR Page 1 of 1

We hereby confirm that we produce PENTAVITIN® without using solvents, and therefore PENTAVITIN® does not contain residual solvents from our manufacturing process.



Product Information



© DSM Nutritional Products Ltd., 2015 Product Code: 5033152Global Regulatory Affairs & Quality Management Personal Care Version Date: 21.04.2016PO Box 2676 Replaces Version: 10.12.2015CH-4002 Basel/Switzerland Ref: DM/CFJ

Page 1 of 1

PENTAVITIN®

Pesticide Statement

This confirmation refers to the definition and limits of pesticide residues as laid down in the internationalpharmaceutical or food regulations, such as the European Pharmacopoeia or Regulation (EC) No396/2005¹, applying to ingredients derived from vegetable sources.

We hereby confirm that above mentioned product contains ingredient(s) of vegetable origin.

Based on the ingredient(s) or product information available, we confirm that compliance with the limitsfor pesticide residues as set in the European Pharmacopoeia (current version) and/or in Regulation (EC) No396/2005¹ and/or equivalent regulation is warranted.

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

Product Information



© DSM Nutritional Products Ltd., 2015 Product Code: 5033152Global Regulatory Affairs & Quality Management Personal Care Version Date: 03.06.2016PO Box 2676 Replaces Version: 13.01.2016CH-4002 Basel/Switzerland Ref: AGG

PENTAVITIN®

Compliance confirmation

We hereby confirm that the above mentioned product at the DSM recommended applications and the uselevels, conforms to all the requirements laid down for cosmetic ingredients in the Regulation (EC) No1223/2009¹ 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 inAnnex II

2. Article 14.1. (b) of this Regulation which relates to the absence of restricted substances if not usedin 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 underthe condition that they are technically unavoidable in good manufacturing practices and do notcause damage to human health when applied under normal or reasonably foreseeable conditions ofuse.

¹ and subsequent amendments

Product Information



© DSM Nutritional Products Ltd., 2015 Product Code: 5033152Global Regulatory Affairs & Quality Management Personal Care Version Date: 10.12.2015PO Box 2676 Replaces Version: 28.06.2013CH-4002 Basel/Switzerland Ref: AGG/DM/CFJ

Page 1 of 2

PENTAVITIN®

Fragrance Allergen Statement

Directive 2003/15/EC amending Directive 76/768/EEC relating to Cosmetic Products identifies a number ofsubstances that may cause allergic reactions following dermal application in sensitized individuals. Thesesubstances have to be stated in the ingredients list if present at specified levels in the finished cosmeticproduct.

We hereby confirm that the potential skin allergens¹ are not intentionally added and are not expected tobe present in this product.

¹ see annexed list

Product Information




Page 2 of 2

List of potential allergens:as listed under Directive 2003/15/EC Annex III and Directive 2008/42/EC

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

Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde (Lyral) 31906-04-4

Isoeugenol 97-54-1

Limonene (sum of d, l and dl) 5989-27-5

Linalool 78-70-6

Methyl 2-Octynoate 111-12-6

Product Information




Page 1 of 1

PENTAVITIN®

CMR statement

Article 15 of Regulation (EC) 1223/2009¹ relating to Cosmetic Products prohibits the use of substanceswhich are classified and listed in Annex VI as CMR (Carcinogenic, Mutagenic, Reprotoxic) classes 1a, 1b and2 under Regulation (EC) 1272/2008¹.In some cases the use of CMR classified substances may be allowed if certain conditions are met, includingthe evaluation and approval by the European Scientific Committee for Consumer Safety (SCCS).

We hereby confirm that this product does not contain intentionally added substances classified and listedin Annex VI as CMR 1a, 1b or 2 under Regulation (EC) 1272/2008¹.


Product Information




PENTAVITIN®

Animal Testing Statement

Article 11 (2) (e) of Regulation (EC) No 1223/2009¹ on cosmetic products requires that cosmetic companiesshall keep information on animal tests readily available, including information on animal tests carried outon the finished cosmetic product as well as its ingredients.

We hereby confirm that, this product and its components were not tested on animals by or on behalf ofour company after 11 September 2004, and are in compliance with Regulation (EC) No 1223/2009¹ (Article18).

An update of this statement will be made in the exceptional case that animal tests should be necessary.


Product InformationEU REACh Statement

PENTAVITIN®Product code: 5033152

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

© DSM Nutritional Products Ltd., 2019 Version 03: 2019-01-17Replaces Version 02: 2015-10-22

Page 1 of 2

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:

(§) Annex IV of EU REACh Regulation (EC 1907/2006)1 sets out substances that are exempted from the registration, evaluation and downstream user provisions of REACh as sufficient information is known about them. Those substances are considered to cause minimum risk due to their intrinsic properties.Substances included in Annex IV are exempted from REACh registration (as well as downstream user requirements and evaluation) for all their possible uses irrespective of the tonnage in which they are manufactured or imported (currently or in the future).

(#) Annex V of the EU REACH Regulation sets out substances that are exempted from the registration, evaluation and downstream user provisions of REACh because registration is deemed inappropriate or unnecessary and their exemption does not prejudice the objectives of REACh. Substances included in Annex V are exempted from registration (as well as downstream user requirements and evaluation) for all their possible uses irrespective of the tonnage at which they are manufactured or imported (currently or in the future). In particular, paragraph 8 of Annex V sets out from any registration, evaluation and downstream user provisions of REACh the substances which occur in nature other than those listed under paragraph 7, if they are not chemically modified, unless they meet the criteria for classification as dangerous according to Regulation (EC) No 1272/2008 or unless they are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII or unless they were identified in accordance with Article 59(1) at least two years previously as substances giving rise to an equivalent level of concern as set out in Article 57(f).

Substance CAS No. EINECS/ ELINCS No.

REACH Registration No.

Status

Saccharide Isomerate 100843-69-4 None Not available Exempt, Annex V - Paragraph 8 (#)

Aqua 7732-18-5 231-791-2 Not applicable Exempt, Annex IV (§)

Citric Acid 77-92-9 201-069-1 01-2119457026-42 RegisteredSodium Citrate 68-04-2 200-675-3 01-2119457027-40 Registered

Product InformationEU REACh Statement

PENTAVITIN®Product code: 5033152

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

© DSM Nutritional Products Ltd., 2019 Version 03: 2019-01-17Replaces Version 02: 2015-10-22

Page 2 of 2

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

This document is valid without signature.


Product Information



©DSM Nutritional Products Ltd., 2018 Product Code: 5033152Global Regulatory Affairs & Quality Management Personal Care Version Date: 05.12.2018PO Box 2676 Replaces Version: 10.12.2015CH-4002 Basel/Switzerland Ref: RS/CFJ

Page 1 of 1

PENTAVITIN®

SVHC Statement

The information related to the presence of Substances of Very High Concern (SVHC) is contained in section3 of the Safety Data Sheet of above mentioned product.

Based on product composition and manufacturing process we confirm that the above mentioned productdoes 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

Product Information




Product Code: 50 3315 2

Date: 2014-11-21

Ref:AnGr/K33/2013



PENTAVITIN® Proposition 65 Statement DSM Nutritional Products as a global company is fully committed to ensure the safety of all our raw materials and products to be in compliance with global legislations.

Based on knowledge of the production process, trace amounts of impurities listed under Proposition 65 may be present in chemicals used in the manufacturing process and we can certify that our final product will be below the established maximum limits set below.

Arsenic 1 ppm Lead 1 ppm Mercury 0.1 ppm Cadmium 0.5 ppm Nickel 2 ppm Antimony 2 ppm Formaldehyde 10 ppm

Inclusion rates may vary in finished consumer products due to impact from other ingredients in the final formula. Please consider the above reference values when calculating consumer exposure in the commercially available product.

Product Information


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., 2014 Global Regulatory Affairs & Quality Management P.O. Box 2676 CH – 4002 Basel/Switzerland

Product Code: 5033152

Version date: 05.09.201423 November 2015 Replaces version: 18.01.2012

Ref: EW/JJ/AW

PENTAVITIN®

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 IECSC listing1 or New Chemical

notification done (Y/N/E)

Cosmetic IECIC listing2 or New Cosmetic Ingredient

registration done (Y/N)

Notes banned/restricted

In finished cosmetic product3 CFDA INCI name Chinese

INCI name

Saccharide Isomerate

糖类同分异构体 E Y -

Citric Acid 柠檬酸 Y Y α-Hydroxy

acids and their salts,

esters, max 6% by total acid,

pH>=3.5 (except for

rinse-off, with label

requirement)

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

Product Information


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., 2014 Global Regulatory Affairs & Quality Management P.O. Box 2676 CH – 4002 Basel/Switzerland


Version date: 05.09.2014 Replaces version: 18.01.2012

Ref: EW/JJ/AW

Sodium Citrate 柠檬酸钠 Y Y α-Hydroxy

acids and their salts,

esters, max 6% by total acid,

pH>=3.5 (except for

rinse-off, with label

requirement)

Aqua 水 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.

Product Information

PENTAVITIN

Regulatory Status

© DSM Nutritional Products Ltd., 2015 Global Regulatory Affairs PO Box 2676 CH-4002 Basel/Switzerland

Page 1 of 2



Ref: DM/RS

Country/region1 Chemical Inventory

Chemical

Registration status based on the listing of individual ingredients in inventory and volume exemption applying (Y/N/R/E)

Cosmetic1 (Y/N)

Note: Claims on finished cosmetic products must comply with national cosmetic legislation

Andean No inventory No inventory Y

ASEAN No inventory No inventory Y

Australia AICS Y Y

Canada DSL NDSL ICL

Y - -

Y

China IECSC Y See separate statement

Europe EINECS/ELINCS REACH

Y (CAS 100843-69-4 not on Annex IV, but single sugars exempted)

Y

Japan ENCS (CSCL) E Y

Korea KECI (TCCA) E Y

Mercosur No inventory No inventory Y

Mexico INSQ Inventory is not supported by legal framework

Y

New Zealand NZloC Y Y

Philippines PICCS E Y

Switzerland EINECS/ELINCS Y (CAS 100843-69-4 not on Annex IV, but single sugars exempted)

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)

Product Information

© DSM Nutritional Products Ltd., 2015 Global Regulatory Affairs PO Box 2676 CH-4002 Basel/Switzerland

Page 2 of 2



Ref: DM/RS

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)



Product Information

PENTAVITIN®

© DSM Nutritional Products Ltd., 2012 Toxicology & Kinetics PO Box 2676 CH-4002 Basel/Switzerland

Page 1 of 3


Version date: 21.08.2012 Replaces version: new

Reference: EW/JRP

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.

Acute oral toxicity

Method: Acute oral toxicity was tested in rats according to OECD Guidelines for Testing of Chemicals No. 401 “Acute Oral Toxicity” (adopted 24 February 1987) and Method B1 of Commission Directive 92/69/EEC (Annex V of Council Directive 92/69/EEC). Testing was conducted in 5 male and 5 female rats at the limit dose of 2000 mg/kg bw and under GLP. Result: Unscheduled deaths or signs of toxicity did not occur in any of the animals used. The LD50 (oral, rat) was found to be greater than 2000 mg/kg bw. PENTAVITIN® is considered not to be an acute oral toxicant according to the Directive.

Acute skin irritation

Method: Acute skin irritation was tested on three female rabbits according to OECD Guidelines for Testing of Chemicals No. 404 “Acute Dermal Irritation / Corrosion”, adopted 17 July 1992, and Method B4 of EU Commission Directive 92/69/EEC. Testing was performed under GLP. Dosing was with 0.5 mL of a 20% (v/v) aqueous dilution of PENTAVITIN applied under protective wrap. Result: The 20% PENTAVITIN® dilution applied to the skin did not produce signs of irritation or edema in any of the rabbits; body weight was not adversely affected. The substance is considered to be “not irritating” to rabbit skin.

Acute eye irritation

Method: Acute eye irritation was evaluated in three rabbits according to OECD Guidelines for Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion, adopted 24 February 1987, and Method B5 of EU Commission Directive 92/69/EEC. Testing was performed under GLP. Dosing was with 0.5 mL of a 20% (v/v) aqueous dilution of PENTAVITIN applied into one eye of each rabbit, without rinsing. Result: PENTAVITIN® as a 20% dilution induced only slight conjuctival erythema in one rabbit at the first reading; all other scores were zero in all other time points in each rabbit. Based upon the classification criteria of “Kay and Calandra”, PENTAVITIN® at 20% dilution is considered to be “not irritating” to the rabbit eye.

Product Information


Page 2 of 3



Reference: EW/JRP

Skin sensitization

Method: Testing for allergic skin reaction responses to a 20% v/v aqueous dilution of PENTAVITIN® was conducted according to OECD Test Guideline number 406, “Skin Sensitization”, adopted 17 July 1992, and Method B6 of Commission Directive 92/69/EEC. The Maximization Test design used albino Guinea pigs in a group of 20 for induction and challenge and a concurrent group of 10 animals; the study was GLP compliant. Induction via intradermal injection and topical applications used 20% v/v aqueous dilution; challenge doses were with 20% v/v and 10% v/v applied topically. Results: Responses to both challenge doses were zero in all animals at each time point. The 20% PENTAVITIN solution is considered not to be sensitizing in this test design.

Phototoxicity and photosensitization

Method: A Guideline-standard study design was not available at the time of this testing; however, based on the responses as expected to the positive control substances, the test results are considered to be relevant for assessing the study’s endpoints. The study was GLP-compliant and used albino Guinea pigs dosed once topically with PENTAVITIN as a 20% v/v aqueous dilution and then exposed to UVA irradiation to assess phototoxicity. Photosensitization was evaluated on tape-stripped skin sites; induction was by intradermal injection and topical dosing with the 20% solution followed by 20% and 10% challenge doses with subsequent UVA irradiation. Results: PENTAVITIN® was considered to be non-phototoxic and non-photosensitizing in this study.

Skin irritation after 14 daily doses

Method: A Guideline-standard study design was not available at the time of this testing, which was GLP compliant. PENTAVITIN® as a 20% v/v aqueous dilution was applied under occlusion once daily for 14 consecutive days to 3 male and 3 female Guinea pigs. Results: Adverse skin reactions related to the test substance did not occur in any of the animals during the study. PENTAVITIN® is considered not to be a skin irritant after 14 daily doses.

Product Information




Page 3 of 3



Reference: EW/JRP

Human skin irritation

Method: PENTAVITIN® was applied as a 20% v/v aqueous dilution with occlusive plastic test chambers for 48 hours on the back of 20 volunteers; skin reactions were evaluated after chambers’ removal and then 24 hours later. Results: On the basis of the test results and under the present test conditions it was concluded that PENTAVITIN® does not have irritancy potential.

Mutagenicity

Method: An "Ames test" was performed on Salmonella typhimurium and Escherichia coli in accordance with the bacterial mutagenicity Test Guidelines published in the Japanese and United States regulations, as well as the OECD guideline No. 471. Testing was GLP compliant and used the undiluted PENTAVITIN® up to a dose of 5000 µg/plate. Result: Significant increases in the frequency of revertant colonies did not occur in any of the bacterial strains with any dose of the test material, either with or without metabolic activation. PENTAVITIN® was shown to be not mutagenic.

Genotoxicity Method: This non-GLP compliant study to assess genotoxicity endpoints followed the procedures of the OECD Guideline 487 for the Testing of Chemicals, adopted 22 July 2010, “In vitro Mammalian Cell Micronucleus Test.” PENTAVITIN® as received was applied to CHO cells in vitro up to 5000 µg/mL both without and with metabolic activation by liver S9 fraction. Results: Cytotoxicity and cytostasis did not occur and the test substance either without or with metabolic activation did not cause an increase in the frequency of micronucleated cells. Positive controls reacted as expected. PENTAVITIN® is considered to be not genotoxic by this test design.

1,00 ECO-ENF363(GC)v07en

Issued the: 04/01/2019

Attestation n°: 852558

ATTESTATION OF CONFORMITY- RAW MATERIALS -

ECOCERT COSMETICS

This attestation has been granted by ECOCERT Greenlife to the company:

DSM NUTRITIONAL PRODUCTS LTD

case postale 26764002 BASEL

SWITZERLAND

whose non-organic raw materials (listed hereafter) have been assessed as compliant to the current version of the ECOCERT standard:

NATURAL AND ORGANIC COSMETICS

This attestation of conformity has been issued on the basis of the terms and conditions for the verification of raw materials according to the ECOCERT standard defining Natural and Organic Cosmetics available on the ECOCERT

website: http://www.ecocert.com and the conformity has been established according to the requirements related to the raw materials contained in this standard.

Issued in : L'Isle Jourdain,the: 04/01/2019,

by: Matthieu BouffartigueRaw materials service manager

Valid until: 31/12/2019

ECOCERT Greenlife S.A.S. - Capital 50 000 € - BP 47 - 32600 L’ISLE JOURDAIN - FRANCE TVA Intracommunautaire n° FR 55 509 534 095

Phone: +33 5 62 07 50 16 - Fax: +33 5 62 07 74 96 - Mail: [email protected]

Page 1 of 2

F363(GC)v07en



ATTESTATION OF CONFORMITY - ECOCERT COSMETICS

List of the approved raw materials of: DSM NUTRITIONAL PRODUCTS LTD

Nat : Natural or from natural originVeg: Physically processed vegetal ingredientsSynth: Synthetic (petrochemical)

Unless an exception, the following references are published on the ECOCERT raw materials online database for approved raw materials available at the following link: http://ap.ecocert.com/ecoproduits

Commercial name / INCI / Function %Nat %Veg %SynthApproved

sinceRestriction

01/01/2019ERYTHRULOSE (5038282)Erythrulose

Active ingredient

100 0 0

01/01/2019HYALURONIC ACID BT (5033462)Sodium Hyaluronate

Active ingredient

100 0 0

01/01/2019PENTAVITIN (5033152)Saccharide Isomerate (and) Aqua (and) Citric Acid (and) Sodium Citrate

Active ingredient

100 0 0

01/01/2019STIMU-TEX® AS (5033365)Butyrospermum Parkii (Shea) Butter Extract (and) Argania Spinosa Kernel Oil (and) Spent Grain Wax (and) Tocopherol

Active ingredient

100 67 0

Valid until: 31/12/2019WARNING: The sole purpose of the present attestation is to allow the raw material(s) to be used in finished products to be certified as compliant to the standard specified in the first page. In no event this attestation should constitute proof of the actual certification of the conformity of the raw material(s) to this standard. In that context, the raw material(s) listed in this attestation must not be qualified and / or marketed as «organic» raw material(s) certified in accordance with the abovementioned standard.The approval of the raw material (s) listed in the present attestation is personally addressed to the above-mentioned beneficiary. It is the beneficiary’ s liability to ensure that its own customers are aware of the requirements and prohibitions defined in the terms and conditions and governing any reference to and use of the approval of the raw material(s) and that they abide by it.



Page 2 of 2

Certi

ficate

Frick, 16.12.2015

bio.inspecta AG Ackerstrasse • CH-5070 Frick • Telefon +41 (0)62 8656300 • www.bio-inspecta.ch

This certificate entitles the holder to use the NATRUE label in accordance with the

contract “Agreement on the usage of the label” with NATRUE.

Document Number: BVH-329562015-04

BVH-329562015-01

BVH-329562015-01

BVH-329562015-01

BVH-329562015-01

Page 1 of 2

DSM Nutritional Products Ltd. Branch Pentapharm Dornacherstrasse 112 4147 Aesch

bi-Nr. 32956

This certificate confirms that the raw materials listed on the following pages of the named company comply with the NATRUE criteria for natural

cosmetics, natural cosmetics with an organic portion and organic cosmetics.

This product certification is valid for 24 months from the date of issue of the certification.

Peter Jossen President of board of directors

Ueli Steiner Director

Date of certification:

Date of the audit:

20.10.2016

13.10.2015

Certi

ficate

bio.inspecta AG Ackerstrasse • CH-5070 Frick • Telefon +41 (0)62 8656300 • www.bio-inspecta.ch

This Page is only valid together with the first page of this document no. BVH-329562015-04

Document Number: BVH-329562015-04 BVH-329562015-01

Page 2 of 2

DSM Nutritional Products Ltd. Branch Pentapharm Dornacherstrasse 112 4147 Aesch

bi-Nr. 32956

The following raw materials are certified:

Pentavitin ® (50 3315 2) 2% natural (0% organic)

48% Water

50% derived natural

0% nature-identical

1,00 COS-ENF363(COS)v08en



ATTESTATION OF CONFORMITY- RAW MATERIALS -

COSMOS

This attestation has been granted by ECOCERT Greenlife to the company:

DSM NUTRITIONAL PRODUCTS LTD

case postale 26764002 BASEL

SWITZERLAND

whose non-organic raw materials (listed hereafter) have been assessed as compliant to the standard:

COSMOS (v3.0 – September 2018)

This attestation of conformity has been issued on the basis of the terms and conditions for the verification of raw materials according to the COSMOS standard available on the COSMOS association website:

https://cosmos-standard.org/ and the conformity has been established according to the requirements related to the raw materials contained in this standard.

Issued in : L'Isle Jourdain,the: 04/01/2019,

by: Matthieu BouffartigueRaw materials service manager

Valid until: 31/12/2019



Page 1 of 2

F363(COS)v08en



ATTESTATION OF CONFORMITY - COSMOS

List of the approved raw materials of: DSM NUTRITIONAL PRODUCTS LTD PPAI: Physically Processed Agro-Ingredients CPAI: Chemically Processed Agro-Ingredients NNI: Non Natural Ingredients (Petrochemical origin) PeMo: Petrochemical MoietyCSPO: Raw material proceeding from certified sustainable palm/palm kernel oil

The asterisk * is used to identify the commercial name of the raw materials concerned by the appendices II and/or V of the Cosmos-standard.Unless an exception, the following references are published on the ECOCERT raw materials online database for approved raw materials available at the following link: http://ap.ecocert.com/ecoproduits.

Commercial name / INCI / Function %PPAI %CPAI %NNI %PeMoApproved

sinceRestriction

PENTAVITIN (5033152) Saccharide Isomerate (and) Aqua (and) Citric Acid (and) Sodium Citrate

Active ingredient

0 67,1 0 0 01/01/2019

Valid until: 31/12/2019WARNING: The sole purpose of the present attestation is to allow the raw material(s) to be used in finished products to be certified as compliant to the standard specified in the first page. In no event this attestation should constitute proof of the actual certification of the conformity of the raw material(s) to this standard. In that context, the raw material(s) listed in this attestation must not be qualified and / or marketed as «organic» raw material(s) certified in accordance with the abovementioned standard.The approval of the raw material (s) listed in the present attestation is personally addressed to the above-mentioned beneficiary. It is the beneficiary’ s liability to ensure that its own customers are aware of the requirements and prohibitions defined in the terms and conditions and governing any reference to and use of the approval of the raw material(s) and that they abide by it.



Page 2 of 2

ProductName Product Code Halal-ID Product Certificate #

1. PENTAVITIN 5033152 / 180-01 C35442 HC-18DSMF98

Date: September 18, 2018

Document #: 5256.13954.IH180008

Company Name & Address: DSM Nutritional Products, Ltd. PO Box 2676 Postfach, Basel-City CH - 40020 Switzerland

Plant Name & Address: DSM Nutritional Products Ltd. (Pentapharm Branch) Dornacherstrasse 112 Aesch, - 4147 Switzerland

This Certificate is valid until November 30, 2020 and subject to renewal at that

time.

Page 1 of 1

Product Information


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 P.O. Box 2676 CH 4002 Basel/Switzerland

Version date:

Replaces version: References:

Page:

30 October 2013

3 May 2011 SA/LLC/SH/HC/CB

1/1

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. ___________________ 1 and subsequent amendments

Product Information


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 P.O. Box 2676 CH 4002 Basel/Switzerland

Version date:

Replaces version: References:

Page:

30 October 2013

12 April 2011 SA/LLC/SH/HC/CB

1/1

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.

Product Information

Sustainability Throughout the Food Chain

©2014 DSM Nutritional Products LtdGlobal Regulatory Affairs and Quality ManagementPO Box 2676CH-4002 Basel/Switzerland

Version date: 29 March 2017Replaces version: 10 November 2015

Ref: PhB/CFJPage Page 1 of 5

Introduction

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

‘Meeting the needs of the present generation without compromising the ability of future generations tomeet 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 behaviour 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.

This commitment has been recognized by our business community since more than 5 years. DSM isranked in the top five of the Dow Jones Sustainability Index1 since more than 5 years in a row.Furthermore, DSM mode of working meets the Corporate Social Responsibility criteria for its inclusion inthe FTSE4Good Index2.

People+

The People+ concept in our production means that DSM strives for a safe working environment for itsemployees, with a very ambitious target of zero accidents on sites. This is to be achieved by 1) afundamental culture change management leading to better understanding of our processes and theirrisks, 2) a better implementation of risk reducing measures at individual level, and 3) increased peopletraining 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 isdeveloping metrics to evaluate progress in people’s life and participate to global activities to reducemalnutrition (one of the key Millennium objectives).

1 The Dow Jones Sustainability Indexes (DJSI) are a family of indexes evaluating the sustainability performance of the largestcompanies listed on the Dow Jones Global Total Stock Market Index (http://www.sustainability-indices.com/)2 The FTSE4Good Index is a series of ethical investment stock market indices(http://www.ftse.com/Indices/FTSE4Good_Index_Series/)

Product Information





ECO+

The objective of the ECO+ activities within DSM is to reduce the environmental footprint of thecompany’s production systems. In addition, we aim to reduce the environmental footprint of ourcustomers when using our products. We therefore compare our products and solutions with competitivesolutions in the same market and place priorities on solutions and products, which provide our customerswith 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 biotechnology3)

o Reducing the use of energy and water in our processes

- Innovate in new products linked to:

o The reduction of emission from livestock production on farm4

o The reduction of energy consumption for producing foodo 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 sources 5

o Utilizing optimally the natural sources produced in a sustainable way6

3 White Biotechnology is the use of living microorganisms to develop or make useful products. White Biotechnology tends toconsume less in resources than traditional processes used to produce industrial goods (www.europabio.org)4 For more details, see our document: Innovation for sustainable animal production5 For more details, see our document: Sustainable Omega-3 and Omega-6 production6 For more details, see our document: Sustainable Palm Oil

Product Information





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

Omega-3 and Omega-6 fatty acids are essential nutrients for peopleOmega-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 fattyacids from the different natural sources available on our planet.

When producing Omega-3 fatty acids (our MEG-3® product range) from aquatic sources (fish), DSMNutritional Products is committed to the responsible and sustainable use of natural marine sources thatpromote marine biodiversity and will help to safeguard our marine environments and fish stocks forfuture generations. Therefore, DSM Nutritional Products sources fish-derived omega-3 fatty acids fromqualified fisheries. DSM MEG-3 fish oil products has achieved Friend of the Sea certification. With a viewto further promoting sustainable fishing practices, DSM Nutritional Products has built strong relationshipwith government agencies and major Peruvian producers7.

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

7 The Peruvian government is recognized worldwide for its control and regulation of the fishing Industry. Peruvian water iscontinually monitored by the Marine Institute of Peru (IMARPE) to ensure sustainability.

Product Information





Sustainable use of palm oil and derivatives

DSM Nutritional Products provides product forms and preparations enabling the proper and efficient useof the active substances in customers’ products. This creates, for example, an increased stability of theactive 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 thespecific local markets. The use of palm oil in certain formulations provides benefits for the properhandling and use of our products by our customers. Furthermore, the application of our products onlyadds 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 limitsthe use of palm oil to product forms, in which it provides significant benefits in the application. Wesecure the sourcing of palm oil from sustainable sources, considering the environmental and socialimpact of palm oil production, particularly:

- DSM Nutritional Products sources only palm oil from companies proving adherence to the RSPO8

mission, i.e.:

o To advance the production, procurement, finance and use of 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 has been certified as compliant with the RSPO Supply ChainCertification Standard, implementing the «Segregation» and «Mass Balance» approaches. Thiscertification 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 2020.

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

Product Information



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




Innovation in animal nutrition

Livestock production is one of the main contributors of emissions, which may have a detrimental effecton 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 andtype of impacts).

DSM Nutritional Products is active in the field of animal nutrition since more than a century and hasdeveloped 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 thekey elements to reduce the environmental footprint of livestock product, within a given productionsystem. Indeed, the improvement of animal performance leads to:

- Improved feed efficiency (i.e. less raw materials used for the same production of meat, milk, oreggs);

- Decreased numbers of animals needed for achieving the same farm production (e.g., by reducingthe mortality or morbidity, linked to improved animal welfare; improved fertility and animal’slongevity)

- Increased animal metabolism, though micronutrition (i.e., increase the performance of thenatural metabolic use of the nutrients from the diet)

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

Product Information

Lot Code Explanation 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.


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 P.O. Box 2676 CH-4002 Basel/Switzerland

Version date: 15 January 2014

Replaces version: 12 April 2011 Ref: SS/CFJ Page 1 of 1

Technical Dossier

Personal Care

© DSM Nutritional Products Ltd., 2017Personal CarePO Box 2676CH-4002 Basel/Switzerland

Version 02: 19.01.2017Replaces version 01: 03.12.2015

Ref.: CS/AGGPage 1 of 4

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) No1907/2006)

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/orequipment used for the manufacture of the product, the substance(s) is/are not expected to be present andconsequently 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 asynthetic product is not relevant).

Technical Dossier

Personal Care




Definition of criteria


The information on the source of ingredients is based on DSM`s internal knowledge or information provided bysuppliers. One or more sources may apply to an ingredient (listed by its INCI name). In this case the last sourcing step isindicated (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 petroleumderived) and/or ingredients which are made by a chemical reaction of one or several educts to form a new chemicalentity.

Biotechnology: ingredients made from or with microorganisms (e.g. fermentation, hydrolysis by enzymes isolated frombacteria).

Vegetable: ingredients derived from plants in the sense of “botanical ingredients” (for comparison: ingredients derivedfrom sugar(s) from plants and used for fermentation are not “botanical ingredients”). Fungi derived ingredients areincluded 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 areolefins (including ethylene and propylene) and aromatics (including benzene, toluene and xylene isomers) and theirderivatives, 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 concentrationrepresents 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 ortheir 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), brazilnuts (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 productsthereof (referring to EU and US Food Regulation).

Technical Dossier

Personal Care




Other various substances

Formaldehyde and formaldehyde releasers: refers to formaldehyde and formaldehyde releasers as mentioned in theSCCNFP 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-2-nitropropane-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.

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 inCosmetic 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)

4. Regulatory Information

Last animal testing date: toxicological tests done on animals after March 2009 testing dates are indicated in the AnimalTesting Statement according to (EC) No 1223/2009. For animal tests done before March 2009 the last testing date isgiven 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.

Technical Dossier

Personal Care





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


Kosher/Halal status: The product can be either Kosher and/or Halal compliant - based on DSM self-assessment (DSMstatement) - 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 standardapplied to the product is given. The product is either certified by a certifying body or compliant based on DSM self-assessment (audit).


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