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Compliance note · updated Sep 2026

REACH & RoHS for black masterbatch exports: a buyer's compliance checklist

The risk in exporting black masterbatch to the EU is rarely the masterbatch itself — it is undocumented supply. A shipment held at customs because the material passport is thin costs more than the product. Here is what to keep in your vendor file.

By Zoe Lin, Export Manager, E-LUCK (Guangdong Yijuyuan Plastic Industry Technology Co., Ltd.)

1. REACH — registration and SVHC

REACH is the one that catches people out, because the obligation that applies to a masterbatch is not the obligation most buyers have heard of. Get the distinction right and the paperwork becomes obvious.

Masterbatch is a mixture, not an article

The Candidate List obligations split by what you are supplying:

What is suppliedObligationWhat it means in practice
A substance on the Candidate ListArticle 31(1) — safety data sheetThe supplier must provide an SDS.
A mixture that is not classified as hazardous under CLP, containing a Candidate List substance at ≥ 0.1% w/w (0.2% for gases)Article 31(3) — SDS on requestThe SDS is owed when the customer asks for it. If you never asked, you never received it — and silence is not evidence of absence.
An article containing a Candidate List substance above 0.1% w/wArticle 33(1) — information to the recipient; 33(2) — consumers get it within 45 days of askingMinimum: the substance name, plus enough information for safe use.

Black masterbatch is supplied as a mixture. So the document you are entitled to is an SDS under Article 31 — not an Article 33 declaration. The Article 33 duty lands on whoever turns the masterbatch into a part: once you mould or extrude it into a component, that component is an article and the duty is yours, owed to your own customers.

This is the single most common misunderstanding we see in incoming buyer questionnaires. A converter who forwards a supplier's “SVHC: none” email as their own customer declaration has not discharged anything — that email was never addressed to the obligation they hold.

The 0.1% is per component, not per finished product

The threshold is assessed per article — and where an article is a complex object, per component of it. The Court of Justice of the EU settled this in Case C-106/14 (ClientEarth v. Total): a plastic housing, a metal insert and a cable sheath are each assessed on their own weight, not diluted into the weight of the assembled product. A small black part inside a large machine is judged alone — which is exactly the case where a colour concentrate matters.

Two deadlines that run from the date of listing, not from your order

Both clocks start when the substance is added to the list. If your first knowledge of an addition is a customer email, you are already behind.

What is usually, and unusually, at risk in a black masterbatch

Carbon black itself is not a Candidate List substance. The exposure in a masterbatch normally sits in the additive package rather than the pigment: stabilisers, flame retardants, plasticisers and process aids. Two practical notes from the February 2026 additions (below): n-hexane matters to anyone running solvent-based steps or buying additives that carry solvent residues, and the bisphenol family matters where a grade is specified into epoxy, polycarbonate or polyester chains.

2. RoHS — restricted substances for E&E

If the masterbatch ends up in electrical and electronic equipment (connectors, housings, cabling), RoHS restricted substances (lead, cadmium, mercury, etc.) apply. State the end-use up front so the plant can confirm the grade is RoHS-aligned. Our automotive and electronics grades are specified with this in mind.

3. Food-contact film — EU 10/2011 and FDA

For films that touch food (packaging, agricultural film that may contact produce), the relevant rules are EU 10/2011 (and its positive lists) or FDA expectations for the US. This means:

4. The material passport

Keep a small compliance folder per grade: REACH statement, RoHS confirmation (if E&E), food-contact docs (if applicable), and lot certificates. This is what customs and your own QA will ask for, and a certified plant is built to produce it. See our certifications page for the systems we run (ISO 9001 / IATF 16949 / ISO 14001).

5. A buyer's compliance checklist

6. Why plant certification helps

Plants that already run IATF 16949 and ISO 14001 tend to have the document discipline to support compliance out of the box. Buying factory-direct means the compliance paper comes from the maker, not filtered through a reseller who may not hold the original records. For common questions, see our FAQ.

7. The 2026 candidate list changes

The Candidate List is updated roughly twice a year, usually in January and July, though ECHA has recently moved outside that rhythm. Two 2026 developments are worth having in your file.

DateSubstanceBasisWhere it bites
4 February 2026 n-Hexane
CAS 110-54-3 · EC 203-777-6
Article 57(f) — specific target organ toxicity after repeated exposure Used in formulations, polymer processing, coatings and cleaning agents. Relevant to any solvent step in your process, and to additives that carry solvent residues.
4 February 2026 Bisphenol AF and its salts
4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol
Article 57(c) — toxic for reproduction Process regulator and cross-linking agent. Matters where a grade is specified into epoxy, polycarbonate or polyester resin chains.

Those two additions took the Candidate List to 253 entries (ECHA press release ECHA/NR/26/06). Because some entries cover groups of substances, the number of individual chemicals affected is larger than the entry count.

Separately, and importantly not the same thing: on 10 August 2026 ECHA placed 4,4'-methylenediphenol (bisphenol F, BPF) — CAS 620-92-8, EC 210-658-2 — on its registry of SVHC intentions, with a dossier expected on 1 February 2027 (proposed by Sweden, on reproductive toxicity grounds). An intention is not a listing: BPF is not on the Candidate List and carries no Article 33 or SCIP duty today. It was proposed before, consulted on in 2025, and withdrawn in February 2026. BPF is widely used as a bisphenol A substitute in coatings, plastics and adhesives, so it is worth flagging to your formulation team now — but do not let a supplier tell you it is “already banned”, and equally do not let a supplier claim the list is unchanged.

One habit that protects you: ask for the Candidate List version and date a declaration was assessed against. A declaration is only as good as the list it was checked against.

8. What a usable SVHC declaration actually contains

Most supplier declarations fail not because the answer is wrong but because the document cannot be audited. A declaration you can rely on should carry all of the following:

The single biggest red flag is a declaration that reads “our products comply with REACH” with no list version, no date and no threshold statement. It reads like compliance and functions like nothing: it cannot be checked, cannot be updated, and cannot be defended if a customs authority or a customer's auditor asks how the conclusion was reached.

Two smaller ones: a declaration that covers a whole catalogue rather than the grade you are buying, and one dated years ago with no evidence it was ever revisited. The Candidate List changes about twice a year; a static declaration is out of date by construction.

9. Questions buyers ask about REACH and SVHC

Is black masterbatch itself an SVHC?

No. Carbon black is not on the ECHA Candidate List, and black masterbatch is a mixture rather than a substance of very high concern. The exposure normally sits in the additive package — stabilisers, flame retardants, plasticisers and process aids — not in the pigment. That is why a useful declaration is grade-specific: it depends on the formulation, not on the fact that the product is black.

Do I need an Article 33 declaration from my masterbatch supplier?

Generally no. Article 33 applies to articles — objects whose function is determined by shape. Masterbatch is supplied as a mixture, so the document owed to you is a safety data sheet under Article 31, and where the mixture is not classified as hazardous under CLP it is owed on request. The Article 33 duty arises when you convert the masterbatch into a part: that part is an article, and the duty is then yours, owed to your own customers.

We have never asked for an SVHC declaration and never had a problem. Is that a risk?

It is a latent one. The obligation for a non-hazardous mixture is triggered by a request, so a supplier who has never been asked has nothing to show. The exposure appears later: at a customs enquiry, in a customer audit, or when a substance added years ago turns out to require SCIP notification before the goods could be placed on the market. Asking now, and keeping the reply, costs one email and closes the gap retrospectively.

Which version of the Candidate List should a declaration reference?

The current one at the time of issue, with the date stated on the document. Since the list is updated roughly twice a year, a declaration without a list version cannot be checked against anything, and one that is more than a cycle old should be re-requested. Our own declarations state the list date they were assessed against precisely so a buyer can verify rather than trust.

Does the 0.1% threshold apply to the finished product or to the part?

To the part. The Court of Justice of the EU confirmed in Case C-106/14 (ClientEarth v. Total) that the threshold is assessed per article, and for a complex object per component of it. A small black component is assessed on its own weight, not diluted into the mass of the whole assembly — which is why colourants deserve attention even when they are a small fraction of a product.

Is REACH the same as RoHS or the UK REACH SVHC list?

No, and the three are frequently conflated. EU REACH governs substances on their own, in mixtures and in articles across the EU market. RoHS is a separate directive restricting specific substances in electrical and electronic equipment. UK REACH is a separate regime operated by the UK with its own candidate list and its own consultation calendar — a substance may appear on one and not yet on the other. Ask which regime, and which list date, any compliance statement refers to.

What was added to the REACH Candidate List in 2026?

On 4 February 2026 ECHA added n-hexane (CAS 110-54-3) for specific target organ toxicity after repeated exposure, and bisphenol AF and its salts for reproductive toxicity, taking the list to 253 entries. Separately, on 10 August 2026 bisphenol F (CAS 620-92-8) was placed on the registry of SVHC intentions with a dossier expected on 1 February 2027 - an intention is not a listing.

This is general compliance orientation from the E-LUCK technical desk, not legal advice. Confirm the current rules with your importer or a compliance specialist for your specific shipment.

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