THE SUGAR PATCH LLC - MEDICAL TAPE REGULATORY DATA SHEET
Regulatory Data Sheet
THE SUGAR PATCH LLC -hypoallergenic medical tape used for securing wearable medical devices.
The Sugar Patch. All rights reserved. Copying and/or downloading of this information for the purpose of properly utilizing The Sugar Patch products is allowed provided that: (1) the information is copied in full with no changes unless prior written agreement is obtained from The Sugar Patch, and (2) neither the copy nor the original is resold or otherwise distributed with the intention of earning a profit thereon.
This Regulatory Data Sheet is provided by the manufacturer of The Sugar Patch medical tape as a courtesy in response to a customer request.
Document Group: 06-7774-0 Version Number: 23.00
Issue Date: 11/12/24 Supercedes Date: 07/24/24
Spunlaced Nonwoven Medical Tape
Medical Surgical (MedSurg)
SDS (US OSHA)
This product is an article and therefore is not subject to the requirements of the US Occupational Safety and Health Administration’s (OSHA) Hazardous Communications Standard 29 CFR 1910.1200(b)(6)(v) to provide a Safety Data Sheet (SDS).
California Proposition 65
To the best of the manufacturer’s knowledge, this product is in compliance with Proposition 65, and reasonably anticipated use of this product will not result in exposure to any Proposition 65 chemicals that would require a Proposition 65 warning.
China RoHS
This product or part does not exceed the maximum concentration values (MCVs) in China RoHS GB/T 26572-2011 (Requirements of Concentration limits for certain restricted substances in electrical and electronic products), which means
that each of the homogeneous materials within this product is below the following MCVs: (a) 0.1% (by weight) for lead and its compounds, mercury and its compounds, hexavalent chromium and its compounds, polybrominated biphenyls or polybrominated diphenyl ethers; and (b) 0.01% (by weight) for cadmium and its compounds.
CONEG
This product complies with the US CONEG (Coalition of Northeastern Governors) Model Toxics in Packaging Legislation as there is no intentionally added lead, cadmium, hexavalent chromium or mercury, and the sum total concentration of these substances in the product does not exceed 100 ppm by weight.
EU CMRs
This product does not contain an ingredient at >= 0.1% that is classified as a Category 1A or 1B carcinogen, mutagen, or reproductive toxicant according to Annex VI of European Regulation 1272/2008 on Classification, Labelling, and Packaging of Dangerous Substances and Mixtures or that is classified by 3M or its vendors as a Category 1A or 1B carcinogen, mutagen, or reproductive toxicant according to the criteria laid out in European Regulation 1272/2008 on Classification, Labelling, and
Packaging of Dangerous Substances and Mixtures.
EU Endocrine-Disrupting Substances
This product does not contain an ingredient at >= 0.1% that is classified as having endocrine-disrupting properties for whichthere is scientific evidence of probable serious effects to human health and which are identified either in accordance with the
procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)) or, pursuant to the first subparagraph of Article 5(3) of Regulation (EU) No 528/2012 of the European Parliament and the Council (Biocidal Products Regulation).
EU Food Allergens
This product complies with Regulation (EU) 1169/2011 on the provision of food information to consumers, as there is no intentionally added component identified in Annex II of this regulation. Specifically, none of the following are intentionally
added: cereals containing gluten, crustaceans, eggs, fish, peanuts, soybeans, milk, nuts, celery, mustard, sesame seeds, sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/L expressed as sulphur dioxide, lupin, mollusks, and/or derivatives thereof.
EU REACH
Substances listed in Annex XIV of Regulation No 1907/2006 of the European Parliament and the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) are not intentionally added to this product.
EU REACH
Substances listed in Annex XVII of Regulation No 1907/2006 of the European Parliament and the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) are not known to be contained in this product.
EU REACH
This product, including any article that the product is composed of, does not contain at greater than 0.1% by weight a Substance of Very High Concern (SVHC) substance identified according to Article 59 of REACH. This declaration reflects the substances on the candidate SVHC list, effective June 2024.
EU RoHS
This product does not exceed the maximum concentration values (MCVs) set under EU Directive 2011/65/EU (RoHS recast/RoHS 2), as stated in Annex II to that directive. This means that each of the homogenous materials within this product does not exceed the following MCVs: (a) 0.1% (by weight) for lead, mercury, hexavalent chromium, polybrominated biphenyls or polybrominated diphenyl ethers; and (b) 0.01% (by weight) for cadmium.
EU RoHS Phthalates
This product does not exceed the maximum concentration values (MCVs) for phthalates set under EU Directive 2011/65/EU (RoHS recast/RoHS 2), as amended by EU 2015/863, which applies to finished EEE after July 22, 2019 for Category 1-7, 10-11 products and after July 22, 2021 for Category 8 and 9 products. This means that each of the homogeneous materials within this product does not exceed the MCV of 0.1% (by weight) for each of the following phthalates: DEHP, BBP, DBP, and DIBP.
Stockholm Agreement
This product does not contain Persistent Organic Pollutants (POPs) at or above applicable thresholds per Annexes A, B, and C of the Stockholm Convention, May 2004 and subsequent amendments.
Chemicals and/or Compounds of Interest
Acrylamide (CAS 79-06-1) : Not known to contain.
Aflatoxins/Mycotoxins : Not known to contain.
Alkylphenol (AP) : Not known to contain.
Alkylphenolethoxylates (APE) : Not known to contain.
Antimony and (Sb) Compounds : Not known to contain.
Arsenic and (As) Compounds : Not known to contain.
Asbestos : Not known to contain.
Azocolorants and Azodyes : Not known to contain.
Biocides/Preservatives : Biocides/preservatives are not intentionally added for the purpose of protecting the product from the
growth of microorganisms.
Bisphenol A (BPA) (CAS 80-05-7) : Not known to contain.
Butyl Benzyl Phthalate (BBP) (CAS 85-68-7) : Not known to contain.
Butylated Hydroxytoluene (BHT) (128-37-0) : Not known to contain.
Cadmium and (Cd) Compounds : Not known to contain.
Chlorinated Paraffins, Short Chain : Not known to contain.
Chromium and (Cr) Compounds : Not known to contain.
Cobalt and (Co) Compounds : Not known to contain.
Colophony (Rosin) (CAS 8050-09-7) : Not known to contain.
Crystalline Silica : Not known to contain.
Di(2-Ethylhexyl) Phthalate (DEHP) (CAS 117-81-7) : Not known to contain.
Di(Methoxyethyl) Phthalate (DMEP) (CAS 117-82-8) : Not known to contain.
Dibutyl Phthalate (DBP) (CAS 84-74-2) : Not known to contain.
Dibutyl Tin Compounds : Contains. Contains a dibutyl tin compound at <0.1%.
Diisobutyl Phthalate (DIBP) (CAS 84-69-5) : Not known to contain.
Diisodecyl Phthalate (DIDP) : Not known to contain.
Diisononyl Phthalate (DINP) : Not known to contain.
Dimethylacetamide (CAS 127-19-5) : Not known to contain.
Di-n-Octyl Phthalate (DNOP) (CAS 117-84-0) : Not known to contain.
Dioxins and Furans : Not known to contain.
Dyes : Not known to contain.
Flame Retardants (not PBB or PBDE) : Not known to contain.
Formaldehyde (CAS 50-00-0) : Not known to contain.
Gluten : Not known to contain.
Halogenated Compounds : Bromine, chlorine, fluorine, iodine or chemical compounds containing them are not intentionally added.
Halogenated Flame Retardants : Not known to contain.
Hexavalent Chromium and (Cr+6) Compounds : Not known to contain.
Isobornyl Acrylate (CAS 5888-33-5) : Not known to contain.
Jatropha : Not known to contain.
Lead and (Pb) Compounds : Not known to contain.
Materials of Human or Animal Origin : Not known to contain.
Melamine (CAS 108-78-1) : Not known to contain.
Mercury and (Hg) Compounds : Not known to contain.
Nanomaterial : Nanomaterial is not intentionally added in this product. Nanomaterial is manufactured or naturally occurring solid particles for which at least 1% by weight of the primary particles are between approximately 1 and 100 nanometers in at
least one external dimension.
Natural Rubber Latex : This product is not made with natural rubber latex.
Nickel and (Ni) Compounds : Not known to contain.
N-Nitrosamines : Not known to contain.
Nonylphenol (NP) : Not known to contain.
Nonylphenol Ethoxylates (NPE) : Not known to contain.
Nuts : Not known to contain.
Ozone Depleting Chemicals (ODCs) : Not known to contain.
Pentachlorophenol (87-86-5) : Not known to contain.
Pesticides/Antimicrobials (FIFRA) : This chemical or chemical compound is not intentionally added or it does not have a
pesticidal/antimicrobial purpose (i.e., a claim) pursuant to the US EPA's Federal Insecticide Fungicide Rodenticide Act
(FIFRA) regulation.
Phenol (CAS 108-95-2) : Not known to contain.
Phosphorus and (P) Compounds : Not known to contain.
Phthalates : Not known to contain.
Polybrominated Biphenyls (PBB) : Not known to contain.
Polybrominated Diphenylethers (PBDE) : Not known to contain.
Polychlorinated Biphenyls (PCBs) : Not known to contain.
Polycyclic Aromatic Hydrocarbons (PAHs) : Not known to contain.
Polyvinyl Chloride (PVC) : Not known to contain.
Tin and (Sn) Compounds : Contains < .01%
Zinc and (Zn) Compounds : Not known to contain.
PER- and Polyfluoroalkyl Substances (PFAS)
PFAS refers to a broad range of thousands of materials with varying properties and characteristics, which may include high resistance to oil, water, temperature, chemicals, and fire, which makes certain PFAS critical to the functioning of many modern products.
Hydrochlorofluorocarbons (HCFCs) : Not intentionally added.
Per- and polyfluoroalkyl substances (PFAS) : Not intentionally added.
Perfluorooctanesulfonic Acid (PFOS) (CAS 1763-23-1) : Not intentionally added.
Perfluorooctanoic Acid (PFOA) (CAS 335-67-1) : Not intentionally added.