Regulatory Compliance Product Declaration (RCPD) Teldene® H03TF

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REACh (Regulation (EC) No. 1907/2006) of December 18, 2006 and Amendments

Substances of Very High Concern (SVHC)

Global Food Contact Status:

European Union (EU)

Specific Migration Limit (SML) & Overall Migration Limit (OML)

SML Components

Dual Use Additives

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United States (FDA)

China Food Contact

MOSH, MOAH & POSH

Biocompatibility Test Results:

European Pharmacopeia (EP)

Drug Master File (DMF)

US Pharmacopeia (USP)

Bovine Spongiform Encephalopathy (BSE)/Transmissible Spongiform Encephalopathy (TSE)/"Mad Cow":

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Tallow

Halal

Kosher

Food Allergens:

European Union

United States

Biocides

ICH Harmonized Guideline for Elemental impurities

Latex

Heavy metals (ELV Directive 2000/53/EC and its following amendments, final amendment 2013/28/EU)

VDA 270

UL Flammability

Coalition of Northeastern Governors (CONEG)

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European Union (EU) Directive - Packaging and Packaging Waste - 94/62/EC (as amended)

California's Safe Drinking Water & Toxic Enforcement Act of 1986, Proposition 65, May, 2018

Ozone Depleting Chemicals (ODCs):

European Union

United States

Toy Regulations

Global Automotive Declarable Substance List (GADSL)

Phthalates

Persistent Organic Pollutants (POP) – Regulation 1342/2014/EU amending regulation 850/2004/EC

Cosmetic regulation 1223/2009/EC

Plasticizers and Epoxy Derivatives Under Regulation (EC) N.1895/2005

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Dimethyl Fumarate (DMF) - EU Commission Decision 2009/251/EC

Nanomaterials

Other Chemicals

Substance CAS No. Substance CAS No.

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Triclosan (2,4,4’-trichloro-2’-hydroxydiphenyl ether)-Commission Decision of 19 March 2010-

(2010/169/EU)

Conflict Minerals (Dodd-Fran Wall Street Reform and Consumer Protection)

Switzerland "VOC-LENKUNGSABGABE"

Rhode Island Air Toxics

Restriction of Hazardous Substances in Electric and Electronic Equipment (RoHS) – Directive 2011/65/EU,

and Commission Delegated Directive (EU) 2015/863.

Waste Electrical and Electronic Equipment (WEEE) – Directive 2012/19/EU – Annex VII

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Global Chemical Control Regulations

Country/Region Inventory

Composting - CEN Standard EN 13432

Energy Recovery - CEN Standard EN 13431

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