REACH Explained — What Every LED Therapy Device Buyer Needs to Know About EU Chemical Regulations

If you sourced products for the European market in the last decade, you have heard of REACH. If you have heard of RoHS, you have probably wondered: why do we need both? And if you manage supply chain compliance for a company selling LED therapy devices in Europe, you have almost certainly asked: what exactly does REACH require us to do, and what should we ask our manufacturers?

REACH and RoHS are the two pillars of EU chemical regulation — but they work differently, cover different substance scopes, and apply to manufacturers and importers in different ways. Understanding the difference is not academic. It determines what your supply chain documentation obligations are, what you can and cannot import into the EU, and what your customers in Europe are entitled to ask of you.

This article is written from the perspective of an LED therapy OEM manufacturer — explaining what REACH covers, how it interacts with RoHS, what SVHC and SCIP obligations mean in practice, and what buyers should ask manufacturers to provide.

What REACH Is — and What It Is Not

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals — Regulation (EC) No 1907/2006, which came into force on June 1, 2007. It is administered by the European Chemicals Agency (ECHA) in Helsinki.

The core purpose of REACH is to ensure a high level of protection for human health and the environment from the risks posed by chemicals, while maintaining the competitiveness of the EU chemical industry. It does this by placing responsibility on industry — manufacturers and importers — to manage chemical risks.

What REACH is not: REACH is not a product safety directive in the traditional sense. It does not certify products as safe. It does not require pre-market approval of finished products. It is a substance-level regulation that places obligations on the companies that manufacture, import, or use chemical substances and preparations in the EU.

For LED therapy device buyers and manufacturers, REACH creates three primary types of obligations: registration, authorisation (for Substances of Very High Concern), and restriction (Annex XVII).

The Four Pillars of REACH

Pillar 1: Registration

Registration is REACH’s foundational requirement. If a company manufactures or imports a substance into the EU in quantities of one tonne or more per year, that substance must be registered with ECHA.

The registration dossier must include:

The identity and properties of the substance
Guidance on safe use (exposure scenarios, risk management measures)
For substances above 10 tonnes per year: a Chemical Safety Report (CSR) including a thorough hazard assessment and exposure assessment

Why it matters for LED device buyers: The substance registration is the responsibility of the substance manufacturer or EU importer — not the finished product manufacturer. The LED therapy device company does not register substances directly; they depend on their suppliers to have registered the substances in their components.

The practical implication: If a supplier cannot confirm that the substances in their component have been registered with ECHA, those substances may not legally be placed on the EU market in quantities above one tonne per year. The legal responsibility falls on the EU importer of the substance — but the consequence is a supply chain compliance risk for the finished product manufacturer.

Pillar 2: Evaluation

Evaluation is ECHA’s review process. ECHA evaluates:

Dossier evaluation: Checking that registration dossiers meet the data requirements
Substance evaluation: Assessing whether a substance poses a risk to human health or the environment, based on the properties and uses reported in registrations

If substance evaluation identifies a risk concern, ECHA can propose risk management measures — including restrictions or authorisation requirements — that would affect all downstream users of that substance.

Why it matters for LED device buyers: Evaluation can result in new restrictions on substances that are currently in common use. Manufacturers and buyers need to monitor ECHA’s rolling implementation plan (RIP) for substances under evaluation and be prepared to substitute affected substances before restrictions take effect.

Pillar 3: Authorisation — SVHC Management

Authorisation is REACH’s most consequential pillar for finished product manufacturers. REACH requires authorisation for the use of Substances of Very High Concern (SVHCs).

SVHCs are substances that are:

Carcinogenic (Category 1A or 1B)
Mutagenic (Category 1A or 1B)
Toxic for Reproduction (Category 1A or 1B)
Persistent, Bioaccumulative, and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB)
Identified on a case-by-case basis as causing equivalent concern (e.g., endocrine disruptors)

The current REACH Candidate List contains over 240 substances (as of 2024). These are substances that have been identified as SVHC and are candidates for inclusion in the Authorisation List (Annex XIV).

Once a substance is placed on the Authorisation List (Annex XIV), companies must apply for authorisation from ECHA to continue using it — and use is only permitted if the risk is adequately controlled, or if socio-economic benefits outweigh the risks and no suitable alternatives exist.

For LED therapy device buyers and manufacturers: The practical obligation is to monitor the Candidate List and ensure that articles (finished products) containing SVHCs above 0.1% by weight notify ECHA via the SCIP database (Substances of Concern In articles as such or in complex objects). This obligation applies to suppliers placing articles on the EU market — and buyers purchasing from non-EU manufacturers should ensure their suppliers are fulfilling this obligation.

Pillar 4: Restriction — Annex XVII

Restriction (Annex XVII) prohibits or limits the manufacture, placing on the market, or use of substances, mixtures, and articles that contain certain dangerous substances.

Annex XVII covers a wide range of restrictions — including restrictions on specific uses of substances that are otherwise registered. Unlike authorisation (which applies to specific companies), restriction applies broadly to all actors in the EU market.

Annex XVII restrictions relevant to LED therapy devices:

Entry 23: cadmium and its compounds — restriction on cadmium in solders, brazing fillers, and electrical contacts
Entry 27: nickel and its compounds — restriction on nickel release from skin-contact articles
Entry 43: azo colorants and aromatic amines — restriction on azo colorants that can release certain aromatic amines
Entry 51 & 52: phthalates DEHP, BBP, DBP, DIBP — these overlap with RoHS 3 restrictions and are restricted in articles under both REACH Annex XVII and RoHS

REACH vs RoHS — What Is Different

REACH and RoHS are often mentioned together, and they do overlap in their substance restrictions. But they are fundamentally different regulations with different scopes, different mechanisms, and different obligations.

Aspect	REACH	RoHS
Legal basis	Regulation (EC) 1907/2006	Directive 2011/65/EU (as amended)
Substance scope	All chemicals — registered substances, SVHCs, restricted substances	10 specific hazardous substances in EEE
Application to	Substances, preparations, and articles	Electrical and electronic equipment specifically
Registration obligation	Yes — substances >1t/year must be registered with ECHA	No — no registration with ECHA
SVHC/Authorisation	Yes — SVHC list, authorisation required	No
Restriction mechanism	Annex XVII	Annex III
Phthalates	DEHP, BBP, DBP, DIBP restricted under Annex XVII	Same four phthalates restricted under RoHS 3
cadmium	Annex XVII Entry 23 restricts cadmium in solders and contacts	Cadmium restricted at 0.01% under RoHS
Administration	European Chemicals Agency (ECHA)	European Commission (implemented by member states)
Applies to	EU manufacturers and importers of chemicals/articles	EEE placed on EU market — all actors including non-EU manufacturers

The key distinction: REACH applies to all chemicals and articles placed on the EU market — it is a general chemical regulation. RoHS applies specifically to electrical and electronic equipment and restricts a defined list of hazardous substances in that category. Where both regulations restrict the same substance (e.g., phthalates, cadmium), both obligations apply — meeting RoHS does not automatically satisfy REACH, and vice versa.

The SCIP Database — What It Means for Buyers

The SCIP database (Substances of Concern In articles as such or in complex objects) was established under the Waste Framework Directive (Directive 2008/98/EC) but is managed alongside REACH obligations. Since January 5, 2021, companies have been required to submit SCIP notifications to ECHA for articles placed on the EU market that contain SVHCs above 0.1% by weight.

What this means in practice:

If an LED therapy device contains an SVHC above 0.1% by weight — even as a component of a component — a SCIP notification must be submitted to ECHA before the article is placed on the EU market
The SCIP notification is submitted by the company that places the article on the EU market — this is typically the EU importer or the EU-based distributor
For non-EU manufacturers, the obligation falls on their EU-based customer (the importer)
The SCIP data is publicly accessible — EU customers and regulators can look up which SVHCs are in the products they are purchasing

What buyers should ask manufacturers:

Does your product contain any substances on the REACH Candidate List (SVHC list)?
If yes, what is the concentration of each SVHC, and have you submitted a SCIP notification?
Can you provide a REACH compliance declaration confirming no SVHCs above 0.1% by weight — or full disclosure if SVHCs are present?

REACH Compliance in the LED Therapy Device Supply Chain

For LED therapy device manufacturers and their B2B buyers, the practical REACH compliance obligations operate at the supply chain level.

What LED Device Components May Contain REACH-Relevant Substances

Solders and brazing alloys: Traditional tin-lead solders do not contain RoHS-relevant lead under current regulations (they are exempt under RoHS Annex III) — but cadmium in solders is restricted under both REACH Annex XVII (Entry 23) and RoHS. Lead in general has been restricted in selected applications under REACH Annex XVII — confirm the specific application.

Cable jackets and PVC components: Phthalates (DEHP, BBP, DBP, DIBP) are restricted under both REACH Annex XVII and RoHS 3. A cable jacket that is compliant with RoHS 3 is also compliant with the REACH phthalate restrictions — but the supplier declaration should confirm both.

Surface coatings and colorants: Azo colorants that can release aromatic amines are restricted under REACH Annex XVII Entry 43. Some metal-complex dyes and certain bright colorants used in plastic components may be affected. Ask your supplier for declarations confirming the absence of restricted azo colorants.

Metal components: Nickel release from skin-contact metal components (device bezels, conductive elements) is restricted under REACH Annex XVII Entry 27. LED therapy mask bezels and any metal parts that contact the skin must not release nickel above the specified migration limit.

Adhesives and sealants: Some industrial adhesives and sealants may contain restricted substances — particularly chlorinated solvents or certain plasticizers. Confirm substance declarations for all adhesive and sealant materials used in the device assembly.

How to Manage REACH Compliance in Practice

Step 1: Request REACH substance declarations from component suppliers. The standard format for supplier substance declarations is the IMDS (International Material Data System) or the IEC 62474 Declaration Checklist — the same format used for RoHS declarations. Each supplier should confirm:

Which REACH Candidate List (SVHC) substances are present above 0.1% by weight in their component
That the component complies with all applicable REACH Annex XVII restrictions
For substances above 1 tonne/year manufactured in or imported to the EU: confirmation of ECHA registration status

Step 2: Screen components against the REACH Candidate List. Cross-reference the component declarations against the current REACH Candidate List (published and updated regularly by ECHA). The Candidate List is available publicly at echa.europa.eu.

Step 3: Submit SCIP notifications where required. If any component contains an SVHC above 0.1% by weight, ensure a valid SCIP notification has been submitted and the SCIP ID is available for your EU importer’s records.

Step 4: Monitor ECHA updates and substance evaluations. The REACH Candidate List is updated twice per year (in January and July). Substance evaluations are ongoing. Maintain a compliance monitoring process to identify when new SVHCs are added and assess their impact on your supply chain before they affect your products.

Step 5: Maintain documentation for 10 years. REACH compliance records — substance declarations, SCIP notifications, REACH compliance declarations — must be maintained for at least 10 years. This is a legal obligation for EU importers and manufacturers.

Common REACH Mistakes

Mistake 1: Assuming RoHS compliance means REACH compliance. As described above: RoHS and REACH are complementary, not equivalent. A product can be RoHS-compliant and still contain SVHCs above the REACH 0.1% threshold — particularly for substances not covered by RoHS. Verify both.

Mistake 2: Not monitoring the Candidate List updates. The REACH Candidate List is updated twice per year. A substance that is not an SVHC today may be added next month. Build the Candidate List update into your regulatory monitoring calendar and reassess your product compliance each time the list changes.

Mistake 3: Accepting supplier declarations that do not address SVHCs above 0.1%. A generic “REACH compliant” statement is not sufficient. The supplier declaration must specifically address whether any Candidate List substances are present above 0.1% by weight — and provide the CAS number and concentration if they are present.

Mistake 4: Not preparing for the non-EU manufacturer situation. If you are importing from a non-EU manufacturer, the obligation to maintain REACH compliance and submit SCIP notifications falls on your EU-based importer. If your EU importer does not have a regulatory compliance process in place, you have a compliance gap — and it is your supply chain problem.

Mistake 5: Confusing REACH registration with REACH restriction compliance. Registration confirms a substance has been evaluated by ECHA — it does not confirm the substance is safe or unrestricted. A registered substance can still be restricted under Annex XVII. The two obligations are separate and both must be satisfied.

REACH Compliance — Common Questions

Q1: We already require RoHS compliance from our manufacturers. Is REACH compliance covered by the same process?

Partially. The RoHS substance restrictions (especially the phthalates and cadmium) are also restricted under REACH Annex XVII — so a RoHS-compliant cable jacket is typically also REACH-compliant for those substances. However, REACH covers substances far beyond the RoHS list. If a component contains any SVHCs that are not on the RoHS list, a RoHS-only declaration will not reveal them. Request a REACH-specific substance declaration that addresses the Candidate List and Annex XVII — not just the RoHS substance list.

Q2: What does it mean if a component contains an SVHC above 0.1%? Does this make our product illegal to sell in the EU?

Not automatically illegal — but it creates obligations. If an SVHC above 0.1% by weight is present, you are required to: (1) provide sufficient information to downstream users (and ECHA via the SCIP database) to allow safe use, and (2) communicate the presence of the SVHC to your EU importer. The substance is not banned — SVHCs require authorisation, not prohibition — but the compliance obligations must be fulfilled. The preferred long-term approach is to work with suppliers to substitute SVHC-containing materials with alternatives that are not on the Candidate List.

Q3: We are designing a custom OEM LED therapy device. How early in development should we address REACH compliance?

At the component specification stage — before you finalize your Bill of Materials. Request substance declarations from component suppliers during the design phase. Identifying a restricted substance or SVHC after the BOM is finalized means either a design change (expensive) or a compliance gap (risk). Building a REACH-compliant product from the start is significantly cheaper than remediating a non-compliant one.

This article is written from the perspective of an LED therapy OEM manufacturer that maintains REACH compliance documentation for all products sold in the EU market. REACH regulations, the Candidate List, and substance restrictions reflect current status as of 2024. REACH obligations are subject to ongoing updates — always verify current requirements with a qualified regulatory specialist for your specific products and supply chain.