Quick Summary<\/strong><\/p>\n\n\n\n Proposition 65 requires businesses to provide clear warnings before knowingly exposing Californians to chemicals on the state’s list of known carcinogens and reproductive toxicants. The list includes over 900 substances; the relevant ones for resistance bands are:<\/p>\n\n\n\n Phthalate plasticizers are used in some TPE formulations to improve flexibility and processability. Several phthalates are on the CA65 list \u2014 DEHP, DBP, and BBP are the most common. The CA65 thresholds for phthalates are low: DEHP at 1,000 ppm in the finished product is above the no-significant-risk level for carcinogenicity.<\/p>\n\n\n\n The practical situation:<\/strong> Standard TPE resistance band compounds produced for fitness applications typically do not contain phthalate plasticizers \u2014 they achieve flexibility through the polymer structure of the TPE compound itself. However, not all TPE formulations are the same. A factory using a lower-grade TPE compound that includes phthalate softening agents will produce a product that tests above CA65 thresholds.<\/p>\n\n\n\n What to request:<\/strong> A CA65 phthalate test report (ASTM D7809 or equivalent) from an accredited laboratory for the specific TPE compound being used. A factory with established US export history typically has this on file for their standard compounds.<\/p>\n\n\n\n N-nitrosamines form as byproducts of the sulfur vulcanization process used to cure natural latex. Several N-nitrosamines are on the CA65 list as known carcinogens. The regulatory standard measures extractable N-nitrosamine content from the finished band.<\/p>\n\n\n\n What to request:<\/strong> A CA65 N-nitrosamine test report (DIN 10347 or equivalent test method) for the latex compound and vulcanization process in use. Factories using low-nitrosamine accelerator chemistry (thiuram-free or accelerator-specific formulations) will return clean results; those using standard accelerator packages may not.<\/p>\n\n\n\n If a CA65 test confirms above-threshold levels, the required warning on the product or packaging reads:<\/p>\n\n\n\n “WARNING: This product can expose you to chemicals including [X], which is known to the State of California to cause [cancer \/ birth defects \/ reproductive harm]. For more information, go to www.P65Warnings.ca.gov.”<\/p>\n<\/blockquote>\n\n\n\n The warning must appear on the product itself or on the immediate packaging. It cannot be in a pamphlet or on a website alone.<\/p>\n\n\n\n If testing confirms below-threshold levels, no warning is required. The test report serves as your documentation of compliance if a retailer or regulator requests it.<\/p>\n\n\n\n REACH is the EU’s primary chemical regulation framework. For resistance bands sold in EU markets, the relevant restrictions are in Annex XVII (Restrictions) and the SVHC (Substances of Very High Concern) candidate list.<\/p>\n\n\n\n REACH restricts several phthalates in consumer articles to 0.1% by weight of the plasticised material. This restriction is stricter than the CA65 threshold in some cases and applies to all consumer products placed on the EU market, not just products sold in California.<\/p>\n\n\n\n Some compound colorants contain heavy metals \u2014 cadmium, lead, mercury, chromium compounds \u2014 that are restricted under REACH. The risk is higher in products using non-standard colorant formulations or lower-grade pigments. Factories with established EU export history use REACH-compliant colorant systems and can provide documentation.<\/p>\n\n\n\n Chemical processing aids and thermal stabilizers used in TPE compounding can include substances restricted under REACH. These are typically present in very small concentrations and are well-managed by factories producing for EU markets \u2014 but the documentation confirming this is a REACH test report, not a factory declaration.<\/p>\n\n\n\n A REACH compliance test report covers the product against the full restricted substances list. The test is destructive (the sample is consumed in testing) and must be performed on the specific compound formulation being used in production. A factory that changes compound suppliers or formulations needs a new test report for the new formulation.<\/p>\n\n\n\n Cost and timeline:<\/strong> \u20ac250\u2013\u20ac500 per sample from EU-accredited laboratories; 10\u201320 business days. For US-based buyers, accredited labs in China (SGS, Intertek, Bureau Veritas China offices) can perform REACH testing for comparable cost with shorter turnaround.<\/p>\n\n\n\n What to request from the factory:<\/strong> A REACH test report dated within the last 12\u201318 months for the specific compound being used. If the factory does not have a current REACH report, factor the testing cost and timeline into the order schedule.<\/p>\n\n\n\n EN 13568 is the EU harmonized standard for rubber bands. It specifies:<\/p>\n\n\n\n EN 13568 is not universally required for fitness resistance bands \u2014 it was developed primarily for office rubber bands and industrial binding applications. However:<\/p>\n\n\n\n When to request it:<\/strong> If your EU retail buyer or distributor specifies it in their supplier requirements, or if you are positioning the product in a professional or healthcare-adjacent channel where documented performance standards are part of the value proposition.<\/p>\n\n\n\n Amazon’s compliance requirements for resistance bands operate independently of US and EU regulatory requirements and have specific document format requirements:<\/p>\n\n\n\n SDS (Safety Data Sheet):<\/strong> Required for any resistance band listing that triggers Amazon’s dangerous goods review \u2014 which occurs automatically when the listing contains the word “latex” or other flagged terms. The SDS must be formatted to GHS (Globally Harmonized System) standards and identify the product’s composition, allergen information (if applicable), and any relevant regulatory classifications.<\/p>\n\n\n\n Third-party test report:<\/strong> Amazon typically requires a third-party chemical test report from an accredited laboratory when the dangerous goods review is triggered. The report confirms that the product meets applicable chemical safety standards. For TPE bands triggered by a false “latex” flag, the test report confirms the product contains no latex proteins.<\/p>\n\n\n\n Timeline implication:<\/strong> Clearing an Amazon dangerous goods review with complete documentation takes 3\u201310 business days. Without complete documentation, the review process can run 4\u20138 weeks with iterative requests. Submit complete documentation at the time of the first dangerous goods notification.<\/p>\n\n\n\n Before confirming a production order for US or EU market, request from the factory:<\/p>\n\n\n\n US market:<\/strong> – [ ] CA65 test report (phthalates for TPE; N-nitrosamines for latex) \u2014 within 18 months – [ ] Safety Data Sheet (GHS format) \u2014 for any latex product or Amazon listing – [ ] CA65 warning label artwork (if test result requires it)<\/p>\n\n\n\n EU market:<\/strong> – [ ] REACH test report \u2014 within 18 months, covering Annex XVII and SVHC list – [ ] EN 13568 test report (if required by buyer or distributor) – [ ] Latex content declaration (if applicable) – [ ] Country of origin documentation<\/p>\n\n\n\n Both markets:<\/strong> – [ ] Confirmation of which compound formulation the reports apply to (compound identity ties the report to the product)<\/p>\n\n\n\n A factory that provides all of this documentation routinely \u2014 without being asked repeatedly \u2014 is a factory that has produced for these markets before and has a working compliance process. A factory that needs to source the documentation after the request is a factory that is doing it for the first time, which means the timeline and accuracy of the documents is uncertain.<\/p>\n\n\n\n There is no fixed renewal period mandated by CA65 or REACH. However, a test report is only valid for the specific compound formulation tested. If the factory changes their compound supplier, compound formulation, or colorant system, the existing test report no longer covers the changed product. In practice, most buyers treat reports older than 24 months as requiring renewal \u2014 not because the regulation requires it, but because compound formulations can drift over time and the report may not reflect current production.<\/p>\n\n\n\n A CA65 test result above threshold does not prohibit selling the product \u2014 it requires adding the CA65 warning to the product and packaging before sale. The practical options are: (1) add the required warning label and sell with the warning, (2) request the factory reformulate the compound to bring the substance below the threshold and retest, or (3) switch to a factory with a compliant compound formulation. Option 2 is the most common resolution; reformulation and retesting adds 4\u20136 weeks and $300\u2013$500 to the project cost.<\/p>\n\n\n\n China does not have a REACH equivalent. REACH is a European regulation and applies to products placed on the EU market, regardless of where they are manufactured. Chinese factories produce for EU markets regularly and test their products against REACH using accredited laboratories (EU-accredited labs with China offices, or China-based labs accredited under CNAS with EU-recognized scopes). The test report must come from an accredited laboratory \u2014 a factory’s internal declaration of REACH compliance is not sufficient documentation for EU import or retail.<\/p>\n\n\n\n If the compound formulation, colorant system, and production process are unchanged from the previous order, the existing test reports are still valid for the same product. Confirm with the factory that no formulation changes have occurred since the last test. If the factory has changed compound suppliers or colorants since the last test, new testing is required.<\/p>\n\n\n\n Related reading:<\/em> <\/p>\n\n\n\n –\u00a0OEM Resistance Band Sourcing: Complete B2B Guide<\/a>\u00a0\u2014 sourcing framework including compliance documentation in the supplier qualification checklist <\/p>\n\n\n\n\n
\n\n\n\nCalifornia Proposition 65 (CA65)<\/h2>\n\n\n\n
Phthalates (TPE Bands)<\/h3>\n\n\n\n
N-Nitrosamines (Natural Latex Bands)<\/h3>\n\n\n\n
Warning Label Language<\/h3>\n\n\n\n
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\n\n\n\nREACH (EU Registration, Evaluation, Authorisation and Restriction of Chemicals)<\/h2>\n\n\n\n
Phthalates<\/h3>\n\n\n\n
Heavy Metal Colorants<\/h3>\n\n\n\n
Processing Aids and Stabilizers<\/h3>\n\n\n\n
REACH Test Report<\/h3>\n\n\n\n
\n\n\n\nEN 13568: EU Rubber Bands Standard<\/h2>\n\n\n\n
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\n\n\n\nCompliance by Material and Market<\/h2>\n\n\n\n
![\"Latex,](\"https:\/\/wellfitsource.com\/wp-content\/uploads\/2026\/09\/compliance-by-material-and-market.webp\")
<\/figure>\n\n\n\nMaterial<\/th> US Market (CA65)<\/th> EU Market (REACH)<\/th> EU Standard<\/th><\/tr><\/thead> TPE \u2014 standard compound<\/td> Phthalate panel<\/td> Phthalate + SVHC<\/td> EN 13568 (optional)<\/td><\/tr> TPE \u2014 custom compound<\/td> Phthalate panel per formulation<\/td> REACH per formulation<\/td> EN 13568 (optional)<\/td><\/tr> Natural latex<\/td> N-nitrosamine panel<\/td> REACH + latex content declaration<\/td> EN 13568 (optional)<\/td><\/tr> Fabric-covered elastic<\/td> TPE core: phthalate; Fabric: dye REACH<\/td> Fabric + core REACH<\/td> Not typically required<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nAmazon Compliance Documentation<\/h2>\n\n\n\n
\n\n\n\nRequesting Compliance Documentation: A Checklist<\/h2>\n\n\n\n
![\"Compliance](\"https:\/\/wellfitsource.com\/wp-content\/uploads\/2026\/09\/compliance-documentation-checklist.webp\")
\n\n\n\nPREGUNTAS FRECUENTES<\/h2>\n\n\n\n
How often do compliance test reports need to be renewed?<\/h3>\n\n\n\n
What happens if a product fails CA65 testing?<\/h3>\n\n\n\n
Does REACH compliance in China differ from EU REACH?<\/h3>\n\n\n\n
Can we use compliance documents from a previous order if we’re reordering the same product?<\/h3>\n\n\n\n
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