Edition 3

21 October 2022

dermofeel® AP MB
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
dermofeel® AP MB is in full compliance with current Cosmetic Regulation (EC) No 1223/2009.
1.2.1 Raw Material Category/Function
Antioxidant
1.2.2 INCI Declaration
Ascorbyl Palmitate
1.2.3 Composition

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

Ascorbyl Palmitate Vegetable/microbial 100

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.
1.2.4 Additives (e.g. Antioxidants, Preservatives)

INCI CAS No. / REACH Reg. No. EINECS / EC No. Content Function
no additives

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.

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2. Production Process
2.1 General Information on the Production Process
The product is obtained by esterification of ascorbic acid and palmitic acid.

Description and Origin of plant based materials:

Palm (Elaeis guineensis), corn (Zea Mays)

Irradiation: dermofeel® AP MB was not irradiated with γ-rays.

dermofeel® AP MB 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: dermofeel® AP MB is not based on raw materials from species listed in CITES appendices.

GMO Status:
The item contains moieties from corn (including oils and other refined ingredients. During the
production no GMOs and derivatives from GMOs are used. All reasonable measures have been taken
to avoid cross-contamination with GMOs or derivatives from GMOs.
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

none

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 not applicable
VOC NMT 3 % according to SR (Swiss Right) 814.018
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

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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.

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
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
None of these substances have been intentionally added to our cosmetic raw materials.
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).

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2.8 Country of Origin
dermofeel® AP MB is manufactured in: China

3. Animal Testing
We hereby confirm that we have never conducted any animal tests with our product dermofeel® AP
MB 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 dermofeel® AP MB 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

1080 days after production (unopened original packaging)

6. Regulatory Status
6.1 HS-Code: 293627
EU-CN-Code: 29362700
6.2 Regulatory Status (Chemical Regulations)
Europe

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

6‑O‑palmitoylascorbic acid/Ascorbyl Palmitate Exempt; < 1t/Y 137‑66‑6 205‑305‑4

*) 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:

Component Country Inventory yes / no Remark

Ascorbyl Palmitate 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
cosmetic raw materials:

Brazil, Japan, South Korea, USA

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

Component Country Inventory yes / no Remark

Ascorbyl China IECIC yes IECIC No. 04108
Palmitate
Japan JSQI no JSQI specification exists (JSQI No. 100653), but
compliance is not controlled
Japan JCIA yes JCIA No. 552039

7. Toxicology and Ecotoxicology

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

8. Packaging
0.5 kg bottle
80 kg (16 x 5 kg bin)
300 kg (12 x 25 kg box)

9. Other Information
China Raw Material Submission Code: 004108-01292-9891
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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