Regulatory compliance for elastomer components is now a standard part of every drawing package. What used to be a specialist requirement — asked for only when the end product was destined for the EU electronics market or the medical sector — is now assumed on most industrial contracts. A supplier who cannot produce a REACH declaration or a RoHS statement on request is a supplier who cannot sell into most modern supply chains.
Here is what those two frameworks actually require of an elastomer component supplier, what the declaration paperwork should contain, and where the process typically goes wrong.
REACH, in one page
**REACH** — the EU Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals — governs the placing of chemical substances on the EU market. For a rubber component supplier, the practical concern is not the substance registration itself (that is the compound manufacturer's responsibility), but the presence of **Substances of Very High Concern (SVHC)** in the finished component.
An SVHC is a substance on the ECHA candidate list, updated twice a year, that has been identified as carcinogenic, mutagenic, toxic to reproduction, persistent, bioaccumulative, toxic, or otherwise of equivalent concern. If any SVHC is present in the component **above 0.1% by weight**, the supplier is required to communicate that presence to the customer, together with any information needed to allow safe use.
For most modern elastomer compounds, formulated with contemporary additive packages from reputable compounders, the answer to "does this component contain SVHCs above 0.1% by weight?" is "no substances present". That is the answer that goes on the declaration.
Where the answer is "yes" — a legacy compound with a phthalate plasticiser still on the SVHC list, for example — the declaration must name the substance, the CAS number, the concentration range, and any safe-use information.
RoHS, in one page
**RoHS** — the EU Restriction of Hazardous Substances directive — restricts the use of specified hazardous substances in electrical and electronic equipment. It matters when the elastomer component ends up inside an electronic device: a sealing gasket in a display housing, a grommet on a cable entry, an O-ring in a fluid-cooled server rack.
The substances currently restricted include lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), and four phthalate plasticisers added in the 2015 amendment: DEHP, BBP, DBP and DIBP. Each has a maximum concentration threshold (typically 0.1% by weight in the homogeneous material).
For elastomer components, the practical exposure is typically the plasticiser package (particularly on soft NBR grades where phthalates were historically common) and the colourant system (where heavy metals were historically used in certain pigments). Modern compound formulations from reputable suppliers avoid all of these, and the RoHS declaration is a straightforward "compliant" statement.
What a compliance declaration should look like
A useful REACH and RoHS declaration, whether combined on one document or issued as two, contains:
- The component part number and drawing revision it covers. - The elastomer compound name and supplier grade (with batch reference where possible). - The specific frameworks referenced (REACH regulation number and the current SVHC list version; RoHS directive number and its amendments). - The declaration statement itself — either "compliant" / "no SVHC present above 0.1% weight" or, where substances are present, an explicit listing. - The signatory, position and date. - A reference to the compound supplier's own material safety documentation.
Declarations issued as a scanned generic PDF, without the component or batch identified, are worth almost nothing to a customer's compliance team. The declaration must be traceable to the shipment it accompanies.
Where the process goes wrong
The most common failure mode is timing. A customer places an order, receives the parts, and only at incoming inspection asks for the declaration. The supplier scrambles to find one, the compound supplier is slow to respond, and the parts sit in quarantine for two weeks while paperwork catches up.
The fix is to request the declaration at quotation stage, alongside the drawing. A supplier who cannot provide it at that point cannot provide it in the box either, and it is better to discover that before the order is placed than after.
The second common failure mode is confusion between REACH registration and REACH SVHC declaration. Registration is a chemical-manufacturer obligation, not a component-supplier obligation. A customer asking a rubber component supplier for a "REACH registration" for their gasket is asking for something that does not exist in that form. The correct request is a "REACH SVHC declaration", which is what the supplier can and should provide.
The third is confusion about scope. RoHS applies to electrical and electronic equipment placed on the EU market. A rubber gasket destined for a hydraulic actuator on an off-highway vehicle is not, in itself, subject to RoHS — but if the customer's end product is an EEE product, the customer will ask for a RoHS declaration on every component regardless of individual scope. Providing the declaration is easier than arguing about scope.
Beyond REACH and RoHS
Depending on the sector, additional declarations may be required:
**Conflict Minerals (CMRT / Dodd-Frank section 1502)** — relevant where tin, tantalum, tungsten or gold are present in the assembly. For pure elastomer components, typically not applicable; for bonded assemblies with plated inserts, occasionally yes.
**Proposition 65** — a Californian right-to-know regulation with a long substance list. Common on components destined for the US consumer market.
**FDA / EU 1935/2004** — food contact compliance, with defined migration limits and permitted substance lists.
**USP Class VI, ISO 10993** — medical biocompatibility standards, with testing typically performed on the compound and certified by the compounder.
**Silicone-free declarations** — required in specific sectors (automotive paint shops, certain semiconductor applications) where silicone contamination causes downstream issues.
Each is a specific set of tests and a specific declaration format. None is difficult in isolation; all should be asked for at quotation stage, not on delivery.
What we provide
Standard REACH SVHC and RoHS declarations accompany every shipment on request, and are compiled from the compound supplier's own current declarations kept on file for every material we run. Where a customer requires additional sector-specific declarations, we ask at quotation stage, source what is needed from the compound supplier, and include it in the FAIR pack or the delivery paperwork as appropriate.
Compliance paperwork is not an incidental deliverable. It is part of the specification of the part. Treating it that way from the first enquiry keeps the process straightforward for everyone downstream.
