Edition 5

20 December 2022

ROVISOME® Biotin
Product Data Record (PDR)
1. General Information
1.1 Supplier
Evonik Operations GmbH
Division Nutrition & Care
Business Line Care Solutions
Rellinghauser Straße 1-11
45128 Essen | Germany
personal-care@evonik.com
https://www.evonik.com/personal-care
1.2 Product Description
ROVISOME® Biotin is in full compliance with current Cosmetic Regulation (EC) No 1223/2009.
1.2.1 Raw Material Category/Function
Cosmetic Active Ingredients in a Phospholipid based Delivery System
1.2.2 INCI Declaration
Aqua; Alcohol; Panthenol; Lecithin; Tocopheryl Acetate; Caffeine; Biotin; Tocopherol
1.2.3 Composition

Components (INCI EU/US) Source Percentage [%]

Aqua/Water 50 – 80
Alcohol Vegetable 10 – 25
Panthenol Synthetic 10 – 25
Lecithin Vegetable 10 – 25
Tocopheryl Acetate Synthetic 1–5
Caffeine Synthetic 1–5
Biotin Synthetic 0.05 – 0.10

This composition information serves for information of our customers only. It is neither relevant for
the composition listing according to Cosmetic Regulation (EC) No 1223/2009, nor does it reflect the
chemical composition according to the different chemical regulations in the world which is disclosed in
the table "information on ingredients/hazardous components" in the relevant parts of the respective
(Material) Safety Data Sheets.

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1.2.4 Additives (e.g. Antioxidants, Preservatives)

INCI CAS No. / REACH Reg. No. EINECS / EC No. Content Function
Tocopherol 10191-41-0/01-2120086658-39 233-466-0 100 – 520 ppm Antioxidant

Unless mentioned in our PDR under section 2.2 (By-Products/ Impurities) or 2.3 (CMR Substances),
no components which are listed in Annex II of the current Cosmetic Regulation (EC) No 1223/2009
are added to and are not to be expected in the above mentioned product, due to the raw materials and
the production process.

2. Production Process
2.1 General Information on the Production Process
ROVISOME® Biotin is obtained by mixing of components.

Description and Origin of plant based materials:

Soy (Glycine), sugar beet (Beta vulgaris)

Irradiation: ROVISOME® Biotin was not irradiated with γ-rays.

ROVISOME® Biotin is produced in the absence of any animal derived material of any type. Based on
the information on the manufacturing process and production site no contamination with BSE/ TSE
risk materials is to be expected.
CITES: ROVISOME® Biotin is not based on raw materials from species listed in CITES appendices.

GMO Status:
The item contains residues from soy and sugar beet (including oils and other refined ingredients).
During the production no GM Crops are intentionally used. Due to the common use of infrastructure
and installations possible cross contamination can not be excluded. Final products will be detected as
PCR negative.
2.2 By-Product/Impurities
Below listed compound are technically unavoidable by-products or traces of unremovable impurities
(e.g. residual solvents). They are not added intentionally.
Information on potentially occuring by - products, impurities and selected substances of general
interest known to be CMR are summarized in section "2.3 CMR Substances".

Known by-products and product specific impurities*

Description Expected values

Theophylline NMT 15 ppm

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 Additional standard parameters**

Description Expected values

Sum of heavy metals (as Pb) NMT 20 ppm
As, Cd, Co, Cr, Cu, Hg, Ni, Pb, Sb each NMT 1 ppm
Residual organic solvents Heptane NMT 125 ppm
Aminopropanol NMT 100 ppm
Methanol NMT 90 ppm
Methylethylketone (MEK) NMT 50 ppm
Toluene NMT 1 ppm
VOC Ethanol approx. 16.5 %
Pesticides meets the valid regulatory requirements for limits on agricultural
pesticides
Latex not to be expected in the product due to the raw materials used
and the production process

* monitored by dedicated product analysis or statistical testing

** monitored by statistical testing and/or spot checks
2.3 CMR Substances
According to Cosmetic Regulation (EC) No 1223/2009 the use of substances classified as CMR
(Carcinogenic, Mutagenic or Reprotoxic) substances of category 1A or 1B or 2, under Part 3 of Annex
VI to CLP Regulation (EC) No 1272/2008 in cosmetic products shall be prohibited.

Some of the CMR substances mentioned below and listed in Annex VI to CLP Regulation (EC) No
1272/2008 may be used as starting materials or solvents for the production of our cosmetic raw
materials and may require reporting under California Proposition 65 or the California Safe Cosmetics
Act, SB 484.

The presence of these substances has to be seen as non-intended and it is technically unavoidable in
good manufacturing practice. Traces of CMR substances can derive from impurities of the starting
materials or the manufacturing process.

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 CMR Substance CAS No. Starting material Max. concentration/ Remark
Ethylene oxide (EO) 75-21-8 no
Propylene oxide (PO) 75-56-9 no
Octamethylcyclotetrasiloxane (D4) 556-67-2 no
2-Ethylhexanoic acid 149-57-5 no
n-Hexane 110-54-3 no
Methyl chloride 74-87-3 no
Dimethyl sulfate 77-78-1 no
Dioxane (1,4-Dioxane) 123-91-1 no
Toluene 108-88-3 no NMT 1ppm
Chloroform 67-66-3 no NMT 1 ppm
Formaldehyde 50-00-0 no For more information on
formaldehyde please refer to our
factsheet available via our
intoBeauty website.
https://intobeauty.evonik.com/

2.4 “Allergens” according to the Regulation (EC) No 1223/2009

The presence of substances, the mentioning of which is required under the column ‘Other’ in Annex III
of Cosmetic Regulation (EC) No 1223/2009, shall be indicated in the list of ingredients in addition to
the terms “Perfume” or “Aroma”.
None of those substances have been intentionally added to our cosmetic ingredients or are formed
during the manufacturing process according to our knowledge of the chemistry. An analytical proof
for the absence of traces of those substances is not performed in our cosmetic ingredients.
2.5 Food Allergens listed on Annex II of Regulation (EU) No 1169/2011
The product contains lecithin, derived from soybeans.
Soybean and products thereof are listed on Annex II (6) of Regulation (EU) No. 1169/2011.
Based on our best knowledge we herewith confirm that:
- no further food allergen was intentionally added and
- none of the other ingredients contained in the product are composed of or made from food allergens
listed on Annex II of regulation (EU) No. 1169/2011.
2.6 Nanomaterial
The product is not a nanomaterial according to the definition given by Cosmetic Regulation (EC) No.
1223/2009, the Commission Recommendation 2022/C 229/01, updating Recommendation
2011/696/EU, and the French Decree No. 2012-232. For details, a separate factsheet is available via
our IntoBeauty website: https://intobeauty.evonik.com/
2.7 Substances of Very High Concern (SVHC)
The candidate list of substances of very high concern is regularly updated and published by ECHA. If
applicable, the information on the substance/s from the candidate list, contained in our product in
reportable amounts, is included in section 3 of the product related Safety Data Sheet (SDS).
2.8 Country of Origin
ROVISOME® Biotin is manufactured in: Germany

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3. Animal Testing
We hereby confirm that we have never conducted any animal tests with our product ROVISOME®
Biotin nor that we have ordered such tests at third parties or third parties have conducted such tests
with our knowledge and acceptance to fulfil the requirements of Cosmetic Regulation (EC) No
1223/2009.

Therefore ROVISOME® Biotin is in full compliance with Cosmetic Regulation (EC) No 1223/2009.

4. Microbiological Status
Total Viable Count: max. 100 cfu/g
Pathogens*: absent/g
* Pathogens are: Enterobacteria, Pseudomonas, Enterococci, Candida albicans, Staphylococci

5. Shelf Life / Storage Conditions

360 days after production (unopened original packaging)
with respect to the specification parameters. ROVISOME® Biotin should be stored in a dark area at
18 – 22 °C in the original packaging and protected from direct sunlight. Keep the container tightly
sealed to prevent microbial contamination. Shake the container well before use.

6. Regulatory Status
6.1 HS-Code: 382499
EU-CN-Code: 38249992
6.2 Regulatory Status (Chemical Regulations)
Europe

Components Chemical Name/INCI REACH Status* CAS No. EINECS / EC No.

Ethanol/Alcohol Reg. No. 64‑17‑5 200‑578‑6
01‑2119457610‑43
Dexpanthenol/Panthenol Reg. No. 81‑13‑0 201‑327‑3
01‑2119953737‑24
Lecithin Exempt; Annex IV 8002‑43‑5 232‑307‑2
3,4‑dihydro‑2,5,7,8‑tetramethyl‑2‑(4,8,12 Reg. No. 7695‑91‑2 231‑710‑0
‑trimethyltridecyl)‑2H‑benzopyran‑6‑yl ace 01‑2120086658‑30
tate/Tocopheryl Acetate
Caffeine Reg. No. 58‑08‑2 200‑362‑1
01‑2119433305‑48
Biotin Exempt; < 1t/Y 58‑85‑5 200‑399‑3
3,4‑dihydro‑2,5,7,8‑tetramethyl‑2‑(4,8,12 Reg. No. 10191‑41‑0 233‑466‑0
‑trimethyltridecyl)‑2H‑benzopyran‑6‑ol/T 01‑2120086658‑39
ocopherol

*) Any REACH registration no. referred to in this document covers the substance manufactured
and/or imported into the European Community by Evonik Operations GmbH (or by our affiliates or by
our EU suppliers). In case that a customer purchases material produced outside the EU which was not
imported into the EU before supply and subsequently imports that material into the EU, this is not
covered by any of our existing REACH registrations.

Non EU - Countries/ Regions:

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Component Country Inventory yes / no Remark
Alcohol Australia AIIC yes
China IECSC yes
Canada DSL yes
Canada NDSL n.a.
Taiwan TCSI yes
Panthenol Australia AIIC yes
China IECSC yes
Canada DSL yes
Canada NDSL n.a.
Taiwan TCSI yes
Lecithin Australia AIIC yes
China IECSC yes
Canada DSL yes
Canada NDSL n.a.
Taiwan TCSI yes
Tocopheryl Acetate Australia AIIC yes
China IECSC yes
Canada DSL yes
Canada NDSL n.a.
Taiwan TCSI yes
Caffeine Australia AIIC yes
China IECSC yes
Canada DSL yes
Canada NDSL n.a.
Taiwan TCSI yes
Biotin Australia AIIC yes
China IECSC yes
Canada DSL yes
Canada NDSL n.a.
Taiwan TCSI yes
Tocopherol Australia AIIC yes
China IECSC yes
Canada DSL yes
Canada NDSL n.a.
Taiwan TCSI yes

In the following countries the relevant authorities currently do not request pre-market approval for

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 cosmetic raw materials:

Brazil, Japan, South Korea, USA

6.2.1 Regulatory Status (Non EU - Cosmetic Regulations)
Other countries:

Component Country Inventory yes / no Remark

Alcohol China IECIC yes IECIC No. 07676
Japan JSQI no JSQI specification exists (JSQI No. 001075), but
compliance is not controlled
Japan JCIA yes JCIA No. 550003
Panthenol China IECIC yes IECIC No. 02292
Japan JSQI no
Japan JCIA yes JCIA No. 552061
Lecithin China IECIC yes IECIC No. 04456
Japan JSQI no JSQI specification exists (JSQI No. 103819), but
compliance is not controlled
Japan JCIA yes JCIA No. 550004
Tocopheryl China IECIC yes IECIC No. 06043
Acetate
Japan JSQI no JSQI specification exists (JSQI No. 540201), but
compliance is not controlled
Japan JCIA yes JCIA No. 552961
Caffeine China IECIC yes IECIC No. 04077
Japan JSQI no JSQI specification exists (JSQI No. 130079,
001197), but compliance is not controlled
Japan JCIA yes JCIA No. 550982
Biotin China IECIC yes IECIC No. 06024
Japan JSQI no JSQI specification exists (JSQI No. 008200), but
compliance is not controlled
Japan JCIA yes JCIA No. 552066
Tocopherol China IECIC yes IECIC No. 06029
Japan JSQI no
Japan JCIA yes JCIA No. 551837

7. Toxicology and Ecotoxicology

Refer to our document: "Summary of Toxicological and Ecotoxicological Data"

8. Packaging
1 kg
5 kg

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9. Other Information
China Raw Material Submission Code: 146864-01292-2990

We emphasize that the recommended in-use concentrations provided in our technical product
documentation/guideline formulations might exceed the historical in-use concentration limits for
Rinse-Off and/or Leave-On products as given in current IECIC.
If the cosmetic product manufacturers would like to use higher ingredient concentration than the
maximum use levels on current IECIC for their products placed on China market, it is their
responsibility to demonstrate safety of those products.

This information and all further technical advice are based on our present knowledge and experience. However, it implies no
liability or other legal responsibility on our part, including with regard to existing third party intellectual property rights,
especially patent rights. In particular, no warranty, whether express or implied, or guarantee of product properties in the legal
sense is intended or implied. We reserve the right to make any changes according to technological progress or further
developments. The customer is not released from the obligation to conduct careful inspection and testing of incoming goods.
Performance of the product described herein should be verified by testing, which should be carried out only by qualified
experts in the sole responsibility of a customer. Reference to trade names used by other companies is neither a
recommendation, nor does it imply that similar products could not be used.

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