Regulatory Product Information

ELASTOSIL® R 401/55 S

RoHS (Restriction of Hazardous Substances)

None of the substances mentioned in Directive 2011/65/EU (RoHS), including subsequent
amendments e.g. Directive 2015/863/EU, are intentionally introduced. Therefore they are not
expected to be present in amounts exceeding the defined limit values.

WEEE (Waste of Electrical and Electronic Equipment)

None of the substances mentioned in Directive 2012/19/EU (WEEE) are intentionally introduced
during manufacture. Therefore they are not expected to be present except for trace amounts from
incidental environmental contamination. Analytical data is not available.

Heavy Metals
► Directive 94/62/EC (Packaging and packaging waste)
► CONEG (Coalition of Northeastern Governors)
► Directive 2000/53/EC (End-of life vehicles)
None of the substances concerned (lead, chromium VI, cadmium, mercury) are intentionally
introduced. Therefore they are not expected to be present except for trace amounts from incidental
environmental contamination. Analytical data is not available.

REACH SVHC (Substances of Very High Concern)

Please see Safety Data Sheet.

Allergens
► Regulation (EU) No 1169/2011, substances listed in Annex II
► Substances listed in the Food Allergen Labeling and Consumer Protection Act (FALCPA)
► Latex
► Fragrances
The substance(s) mentioned above are not used in the manufacture or the formulation of this product.

Regulatory Product Information for ELASTOSIL® R 401/55 S / Version: 1.22 / Date of last alteration: 01/18/2023 / Date of print: 03/19/2024 1/5
GMO (Genetically Modified Organisms)
Product is not derived from genetically modified organisms and for its manufacture no intermediates
and/or auxiliary agents which are genetically modified are used.

BSE/TSE
The product is not derived from human or animal origin and for its manufacture no intermediates
and/or auxiliary agents which are of human or animal origin are used.

Food Contact Regulations

Europe
► Regulation (EC) No 1935/2004
Provided appropriate processing, the product is suitable for the manufacture of food contact materials
and articles according to this Regulation. Compliance with the requirements of Regulation (EC) No
1935/2004, especially the suitability of the material or article for the intended use, the observance of
any given limitations, the effect on taste and smell of the food has to be ensured by the producer of
the finished food contact material or article as it is placed on the market.

► Regulation (EU) No 10/2011

Not applicable. Silicones are exempted from this Regulation.

► Regulation (EC) No 2023/2006

Not applicable. This product is considered as a starting material and therefore out of the scope of this
Regulation.

Germany
► Recommendation of the BfR XV. Silicones
The ingredients of the product and its curing agents Crosslinker C1, C6, E and E2 are in compliance.
Limitation(s): Volatiles max. 0.5%. Extractable substances: max. 0.5%.

If Bis(2,4-dichlorobenzoyl)peroxide (Crosslinker E) is used as curing catalyst, a SML (specific

migration limit) of 5 mg/kg food or food simulant relating to the decomposition product 2,4-
dichlorobenzoic acid, has to be met.

France
► Arrêté du 25 novembre 1992
The ingredients of the product and its curing agents Crosslinker C1, C6 and E are in compliance. The
curing agent Crosslinker E2 is not in compliance with this regulation. Limitation(s): Overall migration
from the final article may not exceed 10 mg/dm² or 60 mg/kg. Volatiles max. 0.5%.

Spain
► Royal Decree 847 of July 2011
The ingredients of the product and its curing agents Crosslinker C1, C6, E and E2 are in compliance.
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Limitation(s): Overall migration from the final article may not exceed 10 mg/dm² or 60 mg/kg.

Switzerland
► Swiss Ordinance SR 817.023.21
The ingredients of the product are listed in annex 9.

USA
The product is suitable for use under the following section(s) of Title 21 of the Code of Federal
Regulations and those which refer to these:

► §177.2600 RUBBER ARTICLES INTENDED FOR REPEATED USE; Extraction limits must be met
on the finished article per 177.2600 (e) & (f).

Limitation(s): The Crosslinker E2 contains 50% of Di(4-methylbenzoyl) peroxide (CAS Reg. No. 895-
85-2), which is subject to following limitations: for use at levels not to exceed 1 percent by weight of
the elastomer, where the total of all accelerators does not exceed 1.5 percent by weight of rubber
product.

China
► Standard GB 9685-2016
The ingredients of this product and its curing agents C1, C6 and E are in compliance for use in
rubber and/or silicone rubber. The curing agent Crosslinker E2 is not in compliance with this
regulation. Limitation(s): for Crosslinker C1, max. use level 1.5% and for Crosslinker E, max. use level
0.4%.

► Standard GB 4806.11-2016
The siloxane based starting substances are listed in Table A.2.

► GB 4806.1-2016
The product meets all applicable requirements of this Standard insofar as it is not classified as
hazardous to human health according to the European classification and labelling requirements.

Brazil/Mercosur States
The base polymers and the curing agents C1, C6 and E are in compliance with the positive list of
starting materials for the manufacture of silicone elastomers under RDC N° 123 of June 19, 2001.
The base polymers, fillers and the curing agents C1, C6 and E are listed in RDC N° 56 of 2012
and/or GMC RES N° 28/99. The curing agent Crosslinker E2 is not in compliance with this regulation.

Limitation(s): Overall migration from the finished article may not exceed 8 mg/dm² or 50 mg/kg food.
For the peroxide crosslinkers a specific migration limit (LME) of 0.5 mg/dm² or 3 mg/kg food must be
maintained.

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Please note:
Unless otherwise stated, no additives/components with an SML are used.

Regulatory sanctioning of the ingredients in a product does not imply that the finished product
manufactured from those ingredients is considered safe for contact with food by regulatory bodies.
The responsibility for compliance of the finished article and any testing requirements relating to
migration, extraction or volatile limits resides with the manufacturer of the finished product.

Toy Regulations
► DIN EN 71-3
Substances mentioned in DIN EN 71-3:2019, table 2 are not intentionally introduced. Therefore they
are not expected to be present except for trace amounts from incidental environmental contamination.
Analytical data is not available.
► DIN EN 71-9
Substances mentioned in DIN EN 71-9:2007, tables 2A – 2I are not intentionally introduced.
Therefore they are not expected to be present except for trace amounts from incidental environmental
contamination. Analytical data is not available.
► CPSIA (Consumer Product Safety Improvement Act) of 2008
None of the substances concerned (lead, phthalates) are intentionally introduced. Therefore they are
not expected to be present except for trace amounts from incidental environmental contamination.
Analytical data is not available.

Substances
► PAH (Polycyclic aromatic hydrocarbons)
► DMF (Dimethylfumarate)
► APEO (Alkylphenol ethoxylates)
► Phthalates
► Azo compounds
► PCDD/PCDF (Polychlorinated dibenzodioxins and dibenzofurans)
► Asbestos
► Melamine
► BPA (Bisphenol A), BPS (Bisphenol S)
► Radioactive substances
► PFOS (Perfluorooctane sulfonate), PFOA (Perfluorooctanoic acid)
► POP (Persistent organic pollutants) as defined in Regulation (EU) 2019/1021 (Stockholm
Convention)
► Conflict minerals as defined in section 1502(e)(4) of H.R. 4173, of the Wall Street Reform and
Consumer Protection Act
► ODS (Ozone Depleting Substances) as mentioned in Regulation (EC) No 1005/2009
► SCCP (Short-chain chlorinated paraffins)
The substances mentioned above are not intentionally introduced. Therefore they are not expected to
be present except for trace amounts from incidental environmental contamination. Analytical data is
not available.

Regulatory Product Information for ELASTOSIL® R 401/55 S / Version: 1.22 / Date of last alteration: 01/18/2023 / Date of print: 03/19/2024 4/5
Irradiation
Product does not undergo any form of radiation treatment.

Chemical Inventory Status

See Safety Data Sheet.

Certificates
Available Certificates can be downloaded via
https://www.wacker.com/cms/de/wacker_group/wacker_facts/ims/certificates/certificates.jsp

This document was created electronically and does not require a signature.

This information is considered accurate and reliable as of the date appearing For questions relating to this data sheet, please
above and is presented in good faith. It is valid from the date of issue unless contact:
legal changes become effective. Because use conditions and applicable laws Wacker Chemie AG
may differ from one location to another and may change with time, Recipient is Hanns-Seidel-Platz 4
responsible for determining whether the information in this document is 81737 München, Germany
appropriate for recipient's use. Since Wacker has no control over how this
information may be ultimately used, all liability is expressly disclaimed and
Wacker assumes no obligation or liability therefore. No warranty, express or
implied, is given nor is freedom from any patent owned by Wacker or others to
be inferred.

Regulatory Product Information for ELASTOSIL® R 401/55 S / Version: 1.22 / Date of last alteration: 01/18/2023 / Date of print: 03/19/2024 5/5