REACH SVHC & Prop 65 for 3D Printed Parts — Building a Declaration Buyers Accept

Why an EU Buyer Asks for a Declaration You Did Not Know You Owed

A European distributor places a first order for 5,000 printed parts, then forwards a one-page form asking for a REACH SVHC declaration, a RoHS statement, a SCIP number and a California Proposition 65 position. For a machine supplier this is routine paperwork. For a part producer it can be the first time anyone has asked for substance information at article level, and the instinct is to sign whatever is placed in front of them. Signing the wrong document is worse than refusing it, because a declaration of conformity is a legally load-bearing statement.

Three regulatory regimes drive nearly all of these requests, and they ask for different things. REACH governs what is in the article and what must be communicated about it. RoHS restricts a short list of substances in electrical and electronic equipment, and a printed part can fall inside scope when it is itself a component of EEE. Proposition 65 governs warnings for exposures in California and is a litigation-driven regime rather than a substance ban. A supplier who answers all three with one sentence usually satisfies none of them.

This article covers the chain from raw inputs to the printed article, the arithmetic that trips people up on the 0.1% threshold, and what a supplier can honestly sign.

What Substance Declaration Does an EU Buyer Need for a 3D Printed Part?

An EU buyer needs an Article 33 communication if any substance on the REACH candidate list is present above 0.1% by weight of the article, a RoHS declaration if the part is part of electrical or electronic equipment, and a SCIP notification in the ECHA database where the SVHC threshold is exceeded. Proposition 65 applies separately to the US California market and is a warning obligation, not a ban.

The rest of this article is about making that answer true, because the difficulty is almost never the wording of the declaration. It is knowing whether the threshold is actually exceeded, and being able to show the buyer the inputs behind the answer.

The Three Regimes Side by Side

The table below is what a buyer should be able to complete with their supplier in a single call, and what each column actually obliges the supplier to do.

Regime	Scope	Threshold	What the supplier owes
REACH Article 33	Any article placed on the EU market	0.1% w/w per article, per SVHC	Information sufficient for safe use, within 45 days of request; proactive if consumer article
REACH SCIP	Articles containing SVHC above 0.1% w/w	Same 0.1% test	Notification to ECHA SCIP database before placing on the market; SCIP number passed down the chain
RoHS 2015/863	Electrical and electronic equipment, and components thereof	0.1% for lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, DIBP; 0.01% for cadmium	Declaration, typically as part of a CE technical file; exemptions must be cited by number
Proposition 65	Products sold in California	No threshold; exposure-based	Clear and reasonable warning, or a documented basis for no warning
IMDS / GADSL	Automotive supply chain	Reporting, not a single threshold	Material data sheet submission to the customer's IMDS entry

The 0.1% Arithmetic Nobody Gets Right First Time

The common mistake is applying the threshold to the raw material instead of to the printed article. The REACH threshold is 0.1% by weight of the article as placed on the market, evaluated per SVHC. That distinction changes the answer in both directions.

Take a printed bracket weighing 42 grams. The filament contains a pigment masterbatch at 2% loading, and the masterbatch itself contains a substance that was added to the candidate list last year at 8% concentration inside the masterbatch. A supplier looking only at the material certificate sees 8% and concludes the part is flagged. The correct calculation is different: 42 g article, 0.84 g of masterbatch, of which 8% is the substance, so 0.0672 g, which is 0.16% of the article. That is above 0.1%, and the obligation is real. Now change the masterbatch loading to 0.5%: the same substance lands at 0.04% of the article, below the threshold, and no Article 33 communication is triggered for that substance.

Two points follow. First, colourant loading is a compliance variable, not only a cosmetic one, and it belongs in the material specification the buyer receives. Second, the calculation must be repeated when the candidate list updates, because a substance that was below the threshold at 0.04% can cross it without anything changing in the product if the supplier's own material formulation shifts.

The Four Input Streams in a Printed Part

Additive parts carry fewer inputs than a moulded assembly, which is an advantage, but each stream needs its own evidence. List them explicitly in the material file:

• Base polymer or resin system. The filament, powder or photopolymer, with grade, colour and lot. Most suppliers stop here. Base polymers are usually the cleanest stream.
• Colourants and masterbatches. Pigments and dyes are the highest-risk stream for heavy metals and certain organic substances, and are frequently dosed at levels that interact with the 0.1% test. Ask for the masterbatch supplier's declaration, not the filament vendor's summary.
• Fillers and flame retardants. Glass fibre, mineral fillers, talc, calcium carbonate, and any halogenated or phosphorus-based flame retardant. Flame retardants are the stream most likely to contain a substance on a restricted or candidate list, and the one where a supplier is most tempted to answer vaguely.
• Process additives and post-treatment. Slip agents, nucleating agents, adhesion promoters, plus anything applied after printing: primer, vapour smoothing solvent, dye, plating base coat, adhesive. Post-treatment chemistry is often bought from a different vendor and left out of the file entirely.

For a filled material the filler fraction matters twice: it dilutes other substances in the weight calculation, and it can itself be the carrier. Our material guide to mineral filled filament covers the loading ranges that are typical, and those loadings change the arithmetic above substantially.

Declarations You Can Sign, and Ones You Cannot

Three different documents arrive labelled "declaration" and they are not interchangeable.

• Statement of composition. Factual disclosure of what is in the part, based on supplier data and your own calculations. This is the document a part producer is actually in a position to issue.
• Declaration of conformity. A claim that the product meets a named directive or regulation, usually tied to CE marking and a technical file. Issue this only for obligations you have assessed and can defend, with the responsible person identified.
• Customer-specific compliance certificate. A form the buyer wrote, often combining REACH, RoHS, Prop 65 and conflict minerals in one page. Read every line; the fourth or fifth item is usually outside anything the part producer can see.

The line a supplier should not cross is signing a blanket statement that the article contains no SVHC above 0.1% without the calculation behind it. If a candidate-list substance appears later, the signed statement becomes evidence of a false declaration rather than an honest error. A qualified statement, naming the candidate list version used and the date of the underlying supplier declarations, is both defensible and more useful to the buyer.

SCIP: The Notification Most Suppliers Skip

SCIP is the part of the obligation that catches people who did the Article 33 work correctly. Where an article contains a candidate-list substance above 0.1% w/w, the EU supplier must submit information to the ECHA SCIP database before placing the article on the market, and pass the resulting SCIP number down the chain. A non-EU manufacturer does not submit directly; the EU importer or distributor does, which means the manufacturer's job is to provide the data in a usable form.

Practically, that means the material file should be structured so an importer can complete a SCIP submission without a second round of questions: article identity and part number, the substance name and CAS number, the concentration range, the safe use information, and the location of the substance in the article. The last item is where additive parts are actually simple, because the substance is normally homogeneously distributed in the polymer rather than in a discrete component, and that statement alone saves the importer a lot of guesswork.

Proposition 65 Is Not a Substance Ban

California's Proposition 65 requires a warning for products that expose users to listed chemicals above specified levels, and it is enforced mainly through private litigation. The list is longer and more dynamic than the REACH candidate list, and it includes substances that are perfectly legal to sell with a warning. That makes the honest supplier answer different from the REACH answer.

For a printed industrial part, the usual exposure pathways are dermal contact during handling or installation, and inhalation in high-temperature applications. A position paper that names the listed substances evaluated, the exposure route considered, and the basis for a warning or no warning is far more useful to a US distributor than a blanket "Prop 65 compliant" line. Machinery and machine components have generally been treated as outside the consumer-product warning framework, but parts sold loose into consumer or consumer-adjacent channels do not automatically inherit that position, and the channel decides.

Where This Sits Against Machine-Level Compliance

Machine compliance and part compliance are separate files, and buyers conflate them constantly. The machine file is about CE, FCC, UL listing and the RoHS status of the electronics inside a printer; our guide to 3D printer certification and compliance covers that side. The part file is about what the polymer in a printed bracket contains. A supplier with a clean machine file may still have an unanswered part file.

Three neighbouring requirements are frequently asked on the same form: food contact, general product safety, and flammability. Food contact is its own migration-based regime rather than a substance list, covered in our food safe 3D printing guide. General product safety for the EU is covered by GPSR and UKCA obligations described in the GPSR and UKCA guide. Flammability performance for printed parts, including UL94 ratings and their limits, is in the flame retardant materials guide. Automotive buyers additionally require data in the IMDS format, and the quality-system context for that chain is in our IATF 16949 comparison.

Building the Documentation Package

The package that satisfies most EU and US buyers is short if it is organised. Six items, refreshed on a defined cadence:

• Material declaration per grade from each of the four input streams, with supplier name, date and the candidate-list version applied.
• Article-level calculation sheet showing the weight fraction of each substance of interest in the finished part, including the loading assumptions for colourant and filler.
• SVHC screening statement naming the candidate list version used and the date it was retrieved, with either a below-threshold statement or the Article 33 information.
• SCIP data block ready for the importer, including substance, concentration range, article identification and safe use information.
• RoHS declaration where the part is a component of EEE, with any exemption cited by number rather than described in prose.
• Prop 65 position stating the substances evaluated, the exposure route and the warning decision.

Two practical disciplines keep the package alive. First, date every document and state the candidate-list version, because a declaration without a version reference expires silently twice a year. Second, tie the package to material lot traceability, so that a supplier-side change to a masterbatch does not leave a stale declaration attached to a new formulation. That lot-level link is described in our incoming material verification guide, and the same lot records are what an auditor will ask for when the declaration is challenged.

What to Ask a Supplier Before You Sign Their Form

Five questions separate a supplier with a real material file from one who will sign anything. Ask for the candidate-list version their declaration references. Ask which of the four input streams they hold supplier declarations for, and in what date range. Ask for the loading percentage of any colourant or flame retardant, because without it the threshold cannot be checked. Ask whether they will support a SCIP submission by the importer with structured data rather than a PDF sentence. Ask whether they will re-issue the declaration within 30 days of a candidate-list update.

A supplier who answers all five in writing is not merely compliant. They have made themselves easy to sell, which matters when the buyer's compliance department is the one approving the purchase order.

Reviewed by the Precise3D OEM & quality team. Regulatory thresholds and candidate-list content change; the figures here reflect the framework in force at the time of writing, including REACH Article 33 and the SCIP database, RoHS Directive 2015/863 and California Proposition 65. This is not legal advice. Confirm the applicable candidate list version, exemption numbers and jurisdictional requirements with your compliance counsel and with the material suppliers in your own chain before issuing a signed declaration.

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