Cosmetic Product Safety Report (CPSR)

(abstract: Part I & IIB)

according to

COSMETICS REGULATION (EC) NO 1223/2009

OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 30 November 2009
on cosmetic products

Product name: EUBOS Haut Ruhe Sonnenschutz Cremegel

Identification of the responsible person:

Dr. Hobein (Nachf.) GmbH, med. Hautpflege

Grenzstraße 2
53340 Meckenheim
Tel.: +49 2225 88940
Product name: EUBOS Haut Ruhe Sonnenschutz Cremegel
Version: 09.03.2023
I Product Description

General information on the product

Product name: EUBOS Haut Ruhe Sonnenschutz Cremegel

Function:
The product was developed as a UV protection cream specifically for babies and toddlers.
It is explicitly recommended as skin care treatment for neurodermatitis.
Galenically it is an O/W emulsion.

Formula Nr.: 150-18-1-4P

Version: of 14.11.2018

Manufacturer: Dr. Hobein (Nachf.) GmbH

Grenzstraße 2
53340 Meckenheim

Responsible person: Dr. Hobein (Nachf.) GmbH, med. Hautpflege

Grenzstraße 2
53340 Meckenheim

2/10
Product name: EUBOS Haut Ruhe Sonnenschutz Cremegel
Version: 09.03.2023

II Cosmetic Product Safety Report

Cosmetic Product Safety Report of the finished product EUBOS Haut Ruhe
Sonnenschutz Cremegel for human health

according to

COSMETICS REGULATION (EC) NO 1223/2009 of 30 November 2009

Product name: EUBOS Haut Ruhe Sonnenschutz Cremegel

Distributor: Dr. Hobein (Nachf.) GmbH

Grenzstraße 2
53340 Meckenheim
Deutschland

Manufacture site: Dr. Hobein (Nachf.) GmbH

Grenzstraße 2
53340 Meckenheim
Deutschland

Responsible person: Dr. Hobein (Nachf.) GmbH

Grenzstraße 2
53340 Meckenheim

Packaging size: 7 ml
50 ml
2,5ml

Purpose/Usage: Body Care/ Sun Care

3/10
Product name: EUBOS Haut Ruhe Sonnenschutz Cremegel
Version: 09.03.2023

II COSMETIC PRODUCT SAFETY REPORT ................................................... 3

1 Assessment conclusion ......................................................................................................................... 5

2 Labelled warnings and instructions of use ............................................................................... 5

3 Reasoning ..................................................................................................................................................... 5
The conclusions set out in Part B (1) are based on the following factors: ............................ 5
3.1 Composition of the finished product............................................................................................. 5
3.2 Microbiological quality and stability of the finished product ............................................... 6
3.3 Information on packaging ................................................................................................................ 6
3.4 Normal and reasonably foreseeable use ..................................................................................... 6
3.5 Raw materials, impurities, traces, toxicological profile ......................................................... 6
3.6 Safety distances of the individual ingredients .......................................................................... 7
3.7 Fragrances; allergenic ingredients ................................................................................................ 7
3.8 Undesirable effects and serious adverse effects ...................................................................... 7
3.9 Other information on the cosmetic product ............................................................................... 7

4 Assessor‟s credentials and approval of part B ...................................................................... 9

4/10
Product name: EUBOS Haut Ruhe Sonnenschutz Cremegel
Version: 09.03.2023

Part B Safety Assessment

1 Assessment conclusion

The product is classified as safe for human health in accordance with the Cosmetic
Regulation (EC) Nr. 1223/2009 of the European Parliament and of the Council of 30
November 2009 on cosmetic products.

The assessment is done in regard of the general toxicological profile of the constituents,
its chemical composition and the exposure, in accordance with the principles of good
manufacturing practice, taking into account the conditions of use and a reasonably
foreseeable use.

2 Labelled warnings and instructions of use

The product does not contain any substances which require special conditions or
warnings on the label for cosmetic products, under Regulation (EC) No 1223/2009.
Furthermore, the product does not contain substances which require special conditions of
use or special warnings on the label, due to their properties and their content in the final
product,
End product specific indications as for aerosol packs are likewise not to be offered.
All required (according to SCCS opinion) Information for UVA/UVB Protection, Precausion
for use an usage Instrucions for sun protection preparations) are stated.
For the application of the product there are on the packaging sufficient indications and
instructions.

3 Reasoning

The conclusions set out in Part B (1) are based on the following factors:

3.1 Composition of the finished product

The product corresponds to its composition according to the Cosmetics Regulation.

5/10
Product name: EUBOS Haut Ruhe Sonnenschutz Cremegel
Version: 09.03.2023

Attention should be taken to the fact that for the preparation of the qualitative
Composition for compounded raw materials, the maximum contents of the individual
ingredients specified by the raw material producer have been taken as a basis. It is
therefore possible that the composition listed here differs from the list on the product. In
addition, listing of the ingredients with a content of <1% is possible in freely selectable
order.

3.2 Microbiological quality and stability of the finished product

The raw materials used correspond to the requirements for cosmetics according to the
attached analytical certificates / specifications / safety data sheets.

The examination of the total germ count according to the product specification as well as
the microbiological challenge test confirm that it satisfies the microbiological
requirements for cosmetics.

3.3 Information on packaging

The primary packaging used complies with the relevant regulations and
recommendations and is suitable as a packaging for cosmetic products.
A chemical interaction of the cosmetic product with the packaging is not to be expected
under normal storage conditions.

3.4 Normal and reasonably foreseeable use

The product is intended for use on the whole Body (external). It is destined to be rinsed
off. Due to the unambiguous application instructions on the product another use can be
excluded.

3.5 Raw materials, impurities, traces, toxicological profile

The assessment is based on the following data:

6/10
Product name: EUBOS Haut Ruhe Sonnenschutz Cremegel
Version: 09.03.2023

- available toxicological and dermatological documentation of the raw materials

- Safety data sheets / Product specifications of the raw materials
- Legal regulations and recommendations of authorities and associations
- generally binding international assessments

The raw materials used correspond to the requirements according to the Cosmetics
Ordinance and as far as verifiable to the present analytical certificates / specifications /
safety data sheets.
The use in the present product with the stated concentration corresponds to the
Cosmetics Regulation. The test of the present formula showed that there are no
conditions for nitrosamine formation, no formaldehyde has been added, and no
formaldehyde donators are added in the formula.
The formula is to be assessed as safe with regard to these substances.

3.6 Safety distances of the individual ingredients

A safe product has Margin of safety (MoS) of at least 100. Differing from this can also be
argued about "Reasoning" and "Weight of Evidence Approach". The present product is
considered to be safe because of its exposure considerations and calculation.

3.7 Fragrances; allergenic ingredients

The product does not contain perfume oils / natural perfume oils which contain allergenic
components subject to labeling.
The "introduction" of these 26 known allergens on extracts and natural oils can also be
excluded.

3.8 Undesirable effects and serious adverse effects

The product has been successfully on the market for several years and has no serious
adverse effects.

3.9 Other information on the cosmetic product

There is no further information on the cosmetic product.

This safety report has been carried out on the basis of today's knowledge (state of the
art). This does not, however, imply warranties or guarantees of properties. Changes to
the formula or the legal provisions may require a revision of the present safety report.

Confirming documents may be inspected at the production site Dr. Hobein, Meckenheim
on request by the Authority.

7/10
Product name: EUBOS Haut Ruhe Sonnenschutz Cremegel
Version: 09.03.2023

Datum: 09.03.2024

Winnie Hortenbach
M.Sc. Food Chemistry
Safety Assessor (DGK)

8/10
Product name: EUBOS Haut Ruhe Sonnenschutz Cremegel
Version: 09.03.2023

4 Assessor‟s credentials and approval of part B

Name Winnie Hortenbach geb. Haag

Date/Place of birth 11.03.1973 in Leisnig, Sa.

Privat adresse: untere Eichstädtstraße 11D

04299 Leipzig

Experience:

Since 04/2023 Manager R&D, Dr. Hobein (Nachf.) GmbH, Meckenheim

2015 – 2023 CEO Undine Kosmetik GmbH

2011 – 2015 Weleda AG, CH-Arlesheim, Teamleader R&D Galenic Development

2009 – 2011 Servicos AG, CH-Aarberg, R&D Manager

2008 – 2009 Ehrmann AG, Freiberg, Product Development Dessert

1996 – 2008 Florena Cosmetic GmbH, Waldheim (BDF-Group)

2006 - 2008, R&D Manager
2005 - 2006, Manager Product Development 2
2002 - 2004, Product Development Surfactants
1997 - 2002, Safety Assessor for cosmetics
1996 - 1997 association for process and packaging technology,
Dresden, research associate

Education:
1991 – 1996 Technical University Dresden
Graduation: Master of Science (Food Chemistry)

Skills / Qualifications:

• Basics of dermatology
• Modern skin care products: development, manufacture and testing
• Theory and practice of sunscreens
• Patent research and statistical analysis
• Principles of the safety assessment of cosmetic products (DGK-Exame)
• Development, production of natural cosmetics (Cosmos, Ecocert, Natrue)
• Regular participation in seminars for safety assessors (DGK, IKW)

9/10
Product name: EUBOS Haut Ruhe Sonnenschutz Cremegel
Version: 09.03.2023

Leipzig, 09.03.2024

Winnie Hortenbach

10/10