REACH vs. FDA vs. RoHS: Which Compliance Standard Actually Applies to Your Formula?
One of the most common questions we hear from founders developing a new product isn’t about ingredients or performance — it’s “which regulations do I even need to worry about?” The answer depends entirely on what you’re making, where you’re selling it, and what it’s made of. Here’s a practical decoder.
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| Framework | Governs | Applies When |
|---|---|---|
| FDA | Cosmetics, personal care, drugs, food-contact materials (US) | You’re selling a cosmetic, OTC drug, or personal care product in the United States |
| REACH | Chemical substances and mixtures (EU) | You’re manufacturing, importing, or selling chemical substances/mixtures — including in finished products — in the EU market |
| RoHS | Restricted hazardous substances in electronics | Your product contains or is packaged with electronic/electrical components (rare for pure formulations, relevant for devices) |
FDA: Cosmetics vs. Drugs Is the First Fork
In the US, the FDA doesn’t pre-approve cosmetics before they go to market the way it does drugs — but the classification of your product as a “cosmetic” versus a “drug” (or both, an OTC drug/cosmetic hybrid) completely changes your obligations.
A product is generally regulated as a drug — not just a cosmetic — if it makes a therapeutic claim: treating acne, blocking UV rays (sunscreen), reducing inflammation, or altering body structure/function. A moisturizer that “hydrates skin” is a cosmetic. A moisturizer that “treats eczema” is a drug, with a different, more rigorous compliance path (often an OTC monograph or NDA).
Practical takeaway: Before you formulate, define your claims. The claims — not the ingredients alone — often determine your regulatory bucket.
REACH: It’s About the Substance, Not Just the Finished Product
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is broader than most people expect. It’s not only a “chemical manufacturer” issue — if you import a finished product containing chemical substances into the EU above certain thresholds, you can have REACH obligations too, particularly around substances of very high concern (SVHCs).
Key things REACH governs:
- Registration of substances manufactured or imported above 1 tonne/year
- Restricted and banned substance lists (Annex XVII)
- Candidate list of SVHCs requiring disclosure obligations
Practical takeaway: If any part of your supply chain touches the EU — manufacturing, importing, or selling — check your formula’s ingredients against the current REACH restricted and candidate lists before finalizing sourcing.
RoHS: Usually Not Your Formula, But Check Your Packaging/Devices
RoHS (Restriction of Hazardous Substances) restricts substances like lead, mercury, and certain flame retardants — but its scope is electrical and electronic equipment (EEE), not chemical formulations themselves. For most cosmetic, cleaning, or industrial chemical formulators, RoHS isn’t directly relevant to the formula.
Where it does matter: if your product ships with an electronic component (a diffuser, an electric applicator device, battery-powered packaging), that component needs RoHS compliance even if the formula inside it doesn’t fall under RoHS at all.
A Quick Decision Framework
What claims are you making?
Therapeutic
claim (US)?
Yes
FDA drug pathway
No
FDA cosmetic pathway
Selling or
importing to EU?
Yes
REACH applies
No
Ships with electronics? Check RoHS
What claims are you making? Therapeutic claims shift US products from cosmetic to drug regulation.
Where are you selling? US-only triggers FDA; EU sales or EU-based manufacturing/import triggers REACH obligations regardless of where you’re headquartered.
Does anything ship with electronics? If yes, RoHS applies to that component specifically.
What industry? Industrial and specialty chemicals often carry additional sector-specific requirements (OSHA, DOT for shipping, sector-specific EPA rules) beyond the three frameworks above.
This article is a starting orientation, not legal or regulatory advice. Compliance requirements are jurisdiction- and product-specific and change over time — always confirm current requirements with a regulatory affairs professional before commercializing a formula.
The Takeaway
Regulatory frameworks aren’t interchangeable checkboxes — each governs a different slice of your product (claims, substances, or components), and most real-world products touch more than one. Mapping your specific formula, claims, and markets against this framework early avoids expensive reformulation or relabeling after launch.
Check individual ingredients against global regulatory status with FormuCheck, or talk to us about a custom formula development brief that accounts for your target markets from day one.
