RoHS and REACH for Indian Plastic Manufacturers: What They Require

RoHS and REACH are not two versions of the same thing. RoHS is a short list of restricted substances in a defined product category. REACH is a general chemicals regulation covering registration, evaluation, authorisation and restriction across almost everything.

Indian manufacturers are asked for both, usually in the same email, and frequently by a customer who does not distinguish between them either. Here is what each actually requires.

RoHS in one page

RoHS – Restriction of Hazardous Substances – applies to electrical and electronic equipment. It restricts specific substances above defined concentration thresholds in homogeneous materials.

The restricted substances:

Substance	Typical threshold
Lead (Pb)	0.1%
Mercury (Hg)	0.1%
Cadmium (Cd)	0.01%
Hexavalent chromium (Cr VI)	0.1%
Polybrominated biphenyls (PBB)	0.1%
Polybrominated diphenyl ethers (PBDE)	0.1%
Bis(2-ethylhexyl) phthalate (DEHP)	0.1%
Butyl benzyl phthalate (BBP)	0.1%
Dibutyl phthalate (DBP)	0.1%
Diisobutyl phthalate (DIBP)	0.1%

Two features of RoHS trip people up constantly.

“Homogeneous material” means what it says. The threshold applies to each individually separable material, not to the finished product. A cable is not one material – the conductor, the insulation, the sheath and the printing ink are each assessed separately. You cannot dilute a non-compliant component by averaging it across the assembly.

It is a product-category regulation. RoHS applies to electrical and electronic equipment. A plastic crate is not in scope; the same plastic used as an appliance housing is.

India has its own equivalent framework for electronics, and other markets have their own RoHS-style regimes. Ask your customer which one they mean – the substance lists overlap heavily but the scope, thresholds and exemptions do not match perfectly.

### What this means for pigments

Several traditional pigments are excluded on a RoHS basis, and they are exactly the ones that used to give the best performance in their shade:

– Lead chromate yellows and oranges – excellent opacity, brilliance and heat stability, and excluded – Cadmium reds, oranges and yellows – outstanding brilliance and heat stability, and excluded – Hexavalent chromium compounds in any form

Modern replacements exist across the whole range. They generally cost more and behave differently, particularly in heat stability, so substituting a compliant pigment into an existing formulation is a reformulation, not a swap. Expect to requalify shade and, in demanding applications, lightfastness.

REACH in one page

REACH – Registration, Evaluation, Authorisation and Restriction of Chemicals – is the European Union’s general chemicals regulation. It is far broader than RoHS and works differently.

The parts that reach an Indian plastics manufacturer:

The Candidate List of Substances of Very High Concern (SVHC). A list that grows at each update. If an article contains an SVHC above 0.1% by weight of the article, the supplier must communicate that down the chain, and notification obligations may apply.

Annex XVII restrictions. Outright restrictions on specific substances in specific uses. Certain azo colourants that can release listed aromatic amines are restricted here, as are various phthalates and other substances relevant to plastics.

Annex XIV authorisation. Substances that cannot be used in the EU without specific authorisation.

Registration. The obligation to register substances manufactured in or imported into the EU above volume thresholds. An Indian exporter does not register directly – the EU importer or an Only Representative does – but you will be asked to supply the data that makes it possible.

The practical difference from RoHS: REACH is largely a disclosure and communication regime, not only a prohibition list. The question is usually “does this contain any SVHC above 0.1%, and can you tell us” rather than “is this substance banned”.

And the list moves. The Candidate List is updated periodically. A declaration issued two years ago was true when written and may no longer be complete. Compliance statements should carry the Candidate List version they were assessed against.

What a declaration is actually worth

This is where most compliance files are weakest.

A supplier declaration is a statement, not evidence. It has value because it creates a contractual obligation and a traceable chain of responsibility. It is not a test result.

A defensible compliance file usually contains:

– Declarations from every material supplier, dated, with the regulation version stated – Test reports on the finished article or on representative samples, from an accredited laboratory – A bill of materials identifying every homogeneous material – A change control process, so a substitution by a supplier triggers a review – A review interval, because the lists change

The change control point is the one most often missing, and it is the one that causes retrospective failures. If your masterbatch supplier substitutes a pigment for a supply reason and does not tell you, your declaration silently stops describing what you are shipping. Put notification of formulation change into the purchase agreement.

Where the risk actually sits in a masterbatch

For a colour or additive concentrate, the substances worth scrutiny are:

Pigments. Heavy metal chemistries as above, plus certain azo pigments under REACH restrictions.

Flame retardants. PBB and PBDE are restricted under RoHS. Other brominated flame retardants appear on REACH lists. This is an active area and the lists change.

Plasticisers. DEHP, BBP, DBP and DIBP are all RoHS-restricted and phthalates feature heavily under REACH. Relevant wherever a plasticised system or a phthalate-carried additive is used.

Stabilisers. Lead-based heat stabilisers, historically standard in PVC, are the clearest example – displaced by calcium-zinc systems in most applications for exactly this reason.

Processing aids and carriers. Less often scrutinised and not exempt.

Our formulations are built from pigment and additive sets selected with these restrictions in mind, and we can provide RoHS and REACH declarations where an application requires them. We manufacture under ISO 9001:2015.

The adjacent requirements

Customers frequently bundle these together in one request:

Food contact – a separate regime entirely, covering migration into foodstuffs, assessed under FSSAI packaging regulations and the relevant Indian Standards for each polymer.

Toy safety – EN 71-3 and IS 9873 Part 3 limit element migration rather than content, which is a genuinely different test. Covered in toy safety and heavy metals.

Conflict minerals, POPs, PFAS and customer-specific restricted substance lists – increasingly common, and a large customer’s own list is often stricter than any regulation.

Do not assume one certificate answers all of these. A RoHS declaration says nothing about food contact, and a food contact certificate says nothing about SVHCs.

A practical sequence

1. Establish which regulations apply – by market, by product category, by customer contract 2. Build a bill of materials down to homogeneous material level 3. Collect supplier declarations with dates and regulation versions 4. Test where the risk or the contract requires it, at an accredited laboratory 5. Write change control into purchase agreements with every material supplier 6. Set a review interval and honour it 7. Keep the file – the burden of proof is on the manufacturer

Talk to us

If you are supplying into an electrical, export or regulated application and need the colour side of your compliance file to be solid, tell us the regulation, the market and your customer’s restricted substance list and we will formulate against it and document what we used.

Related: electrical, automotive, toys, pharma, engineering polymer masterbatch.

FAQs

What is the difference between RoHS and REACH? RoHS restricts ten specific substances above set thresholds in electrical and electronic equipment. REACH is a much broader European chemicals regulation covering registration, disclosure of substances of very high concern, and specific restrictions across almost all products.

What does homogeneous material mean under RoHS? Each individually separable material within a product, assessed separately. In a cable, the conductor, insulation, sheath and printing ink are each homogeneous materials. A non-compliant component cannot be averaged out across the whole assembly.

Which pigments are restricted under RoHS? Lead chromate yellows and oranges, cadmium reds, oranges and yellows, and hexavalent chromium compounds. Compliant alternatives exist across the range but generally cost more and differ in heat stability, so substitution requires requalification.

Is a supplier declaration enough for RoHS compliance? It is a necessary part of a compliance file and not sufficient on its own. A defensible file also needs a bill of materials to homogeneous material level, accredited test reports where risk or contract requires them, change control with suppliers, and a review interval.

What is an SVHC under REACH? A Substance of Very High Concern on the REACH Candidate List. If an article contains one above 0.1 percent by weight, the supplier must communicate that down the supply chain, and notification obligations can apply. The list is updated periodically.

Does REACH apply to Indian manufacturers? Indirectly but substantially. Registration falls on the EU importer or an Only Representative, but the information required comes from you, and restrictions and SVHC disclosure obligations flow back through the supply chain in the form of customer requirements.

Does a RoHS certificate cover food contact? No. They are entirely separate regimes with different scopes and different tests. Food contact concerns migration into foodstuffs and requires its own assessment, as does toy safety, which limits element migration rather than content.

What should I do if my masterbatch supplier changes a pigment? Review your compliance declarations, because they describe the formulation as it was. The better answer is to prevent surprises by writing formulation change notification into the purchase agreement so that any substitution triggers a review before it ships.