Materials & compliance · 8 min read
FDA 21 CFR 177.2600, REACH and RoHS compared
Three regimes, three different jobs. Which one applies depends less on the product than on the market you are entering.
They regulate different things
Buyers frequently read these three as alternative versions of the same certificate. They are not. One is a US material composition rule, one is an EU chemicals regime covering articles generally, and one covers hazardous substances in electrical equipment. A product may need all three, one of them, or none — depending on where it is sold and what it contains.
| Regime | Regulates | Applies because | Evidence |
|---|---|---|---|
| FDA 21 CFR 177.2600 | Composition and extractables of rubber articles intended for repeated use | The US market — adopted as the material benchmark for this category | Material compliance statement and laboratory report |
| REACH | Substances of very high concern in articles | EU market entry | Third-party report against the current candidate list |
| RoHS | Specified hazardous substances in electrical and electronic equipment | The electronic subassembly contains a restricted substance | RoHS conformity report by IEC 62321 methods |
21 CFR 177.2600, stated precisely
This provision of the US Code of Federal Regulations governs rubber articles intended for repeated use in contact with food. It sets composition requirements and limits on extractable substances. Products in this category are not food-contact items — but no FDA standard is written specifically for them either, so compliance with 177.2600 has become the reasonable, widely accepted material benchmark for the US market.
Our own position is stated for precisely this reason: we say the silicone meets this provision, not that anything is approved. The distinction runs through the technology page and every Product node on the model pages, because consistency between the visible claim and the structured data is what stops a crawler quoting the wrong one.
It is a composition rule with extraction limits, verified under stated conditions rather than certified once and forgotten. [U.S. Food and Drug Administration, 2024] is the text to read before accepting any summary of it, including ours.
REACH: the list moves
REACH restricts substances of very high concern in articles placed on the EU market. The relevant list is maintained and updated, which is the operational point most buyers miss: a report from two years ago may no longer cover the current list. Always ask for a report against the version in force when you order, not the version in force when you first qualified the supplier.
For this category the practical screening is usually phthalates and heavy metals in pigments. That is why a new colourway is a compliance event rather than a cosmetic one — noted also in specifying silicone properly.
RoHS: narrower than it sounds
RoHS restricts six substances — and their compounds — in electrical and electronic equipment. In a vibrating product, it governs the electronics rather than the silicone body. It overlaps with REACH on heavy metal pigments, so the two frequently get conflated in conversation, but a product with no electronics would have no RoHS obligation at all.
What to ask for, in one list
- Material compliance statement naming the provision and the component it covers.
- Third-party laboratory report, naming the laboratory, against the current restricted-substance list.
- RoHS report by IEC 62321 methods covering the electronic subassembly.
- MSDS for every skin-contact component.
- Confirmation of what each document does not cover — the most useful sentence in a compliance pack.
Every item above is named and listed for our range in the shipment document set, and cross-referenced by market in the compliance matrix.
References
- European Parliament and Council (2006). Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Official Journal of the European Union.
- European Parliament and Council (2011). Directive 2011/65/EU on the restriction of hazardous substances in electrical and electronic equipment. Official Journal of the European Union.
- U.S. Food and Drug Administration (2024). 21 CFR 177.2600 — Rubber articles intended for repeated use. Code of Federal Regulations, Title 21.
- International Electrotechnical Commission (2013). IEC 62321 — Determination of certain substances in electrotechnical products. Geneva: IEC.
Questions on this guide
Do I need all three?
It depends on destination and construction. EU entry needs REACH; powered products engage RoHS; the US market has no product approval but expects the 177.2600 material benchmark.
How often do these need re-testing?
Whenever the material, pigment or component changes, and periodically thereafter because restricted-substance lists are updated. Ask for reports against the current list rather than accepting archived ones.
Is one standard stricter than another?
They measure different things, so ranking them is not meaningful. A product can pass one and fail another without contradiction.
Is FDA registration the same as FDA approval?
No, and the difference matters on a label. Most non-medical massagers are not subject to premarket approval; what is usually held is a material compliance position against 21 CFR 177.2600. Writing "FDA approved" without a legal basis for it is a claim you will have to defend.
How often does the REACH restricted list change?
The candidate list is updated periodically, roughly twice a year, and substances are added far more often than they are removed. A declaration issued two years ago is a statement about the list as it stood then.
Does RoHS cover the silicone?
No. RoHS restricts substances in electrical and electronic equipment at the level of each homogeneous material, so it reaches the motor, the cell, the board and the cable — not the skin-contact elastomer. That is REACH's job.
Can one test report satisfy all three regimes?
No. They test different things against different limits, and a report that does not name the standard it was tested against is not evidence of anything. The document set we ship lists what each document establishes.
Still open: which of the three rules applies to your market — or read the certificate split by destination.