Research Reagents: Legal Status in Poland and the European Union

The question “is this legal?” is frequently asked about this category, but it is usually framed too broadly. There is no single answer because there is no single legal category. The same molecule may be the active ingredient of an authorized medicinal product, a food ingredient, an unapproved material or a laboratory reagent. The applicable category depends not only on the substance itself, but on its commercial form, intended purpose and presentation.

This page distinguishes the three categories most often confused in practice, outlines the legal framework in Poland and the European Union, and explains why product descriptions in this store are written as they are.

What Is a Research Reagent?

The term Research Use Only (RUO) describes material intended exclusively for laboratory research or analytical use and not intended for use in humans or animals or for diagnostic purposes.

An important point should be clarified at the outset: RUO is not an approval category. It is not a “third license” alongside medicinal products and food supplements. It is a statement of intended purpose that places the material outside the marketing frameworks for products intended for human use. A substance labeled RUO has not been assessed for efficacy or safety in humans because materials in this category do not undergo that approval process.

Laboratory reagents are nevertheless subject to legislation governing chemical substances, principally Regulation (EC) No 1907/2006 (REACH) on the registration and evaluation of chemicals and Regulation (EC) No 1272/2008 (CLP) on classification and labeling.

Three Categories Most Often Confused

The Definition of a Medicinal Product Has Two Parts

This is the central issue and the point that explains the distinctions that follow.

Under Directive 2001/83/EC, a medicinal product is any substance or combination of substances:

• presented as having properties for treating or preventing disease in humans, known as the definition by presentation; or
• which may be used to restore, correct or modify physiological functions through pharmacological, immunological or metabolic action, known as the definition by function.

The first part has a consequence that is often missed: the way a product is described may determine its classification. Material sold as a reagent but presented as treating disease or modifying bodily functions may be classified as a medicinal product placed on the market without authorization, regardless of any small-print disclaimer.

Rule for Resolving Doubts

Directive 2001/83/EC includes a rule for borderline products: where a product, taking all its characteristics into account, falls within both the definition of a medicinal product and the definition of a product governed by other legislation, the provisions governing medicinal products apply. Polish Pharmaceutical Law contains an analogous principle.

In practical terms, the pharmaceutical framework prevails in a borderline case, not whichever category the seller chooses.

What the Absence of Marketing Authorization Means

This phrase is sometimes interpreted as a judgment that the substance is harmful. That is a misunderstanding and should be separated into several distinct points.

• It does not mean that harm has been established. It means that the competent authority has not conducted an assessment, which is a different statement.
• It means that no dosage has been established. Dosage is determined through the registration process. Without that process, there is no authorized value to cite, and figures circulating elsewhere do not come from registration trials.
• It means that no adverse-effect profile has been established. A Summary of Product Characteristics is based on systematically collected study data. Where no such data are collected, the absence of reported events is not evidence of safety.
• It means that manufacturing is not supervised under the framework applicable to medicinal products.

Analytical literature documents the practical consequences of this last point. In a study published in JAMA, only 52% of 44 products marketed as SARMs contained any SARM, while 39% contained another unapproved drug (Van Wagoner et al., 2017, PMID 29183075). Five unapproved drug substances were detected in products marketed for cognitive enhancement (Cohen et al., 2021, PMID 34484905). A European network of official laboratories also tested products suspected of illegal origin for SARMs, metabolic modulators and growth hormone secretagogues (Barrios et al., 2025, PMID 40551438).

Legal Framework and Primary References

European Union

• Directive 2001/83/EC — the Community code relating to medicinal products for human use; it contains the definition of a medicinal product and the rule for resolving borderline cases.
• Directive 2002/46/EC — approximation of Member State laws relating to food supplements.
• Regulation (EC) No 178/2002 — general principles and requirements of food law.
• Regulation (EU) 2015/2283 — novel foods; it covers ingredients not consumed to a significant degree in the EU before May 15, 1997.
• Regulation (EC) No 1924/2006 — nutrition and health claims; unauthorized claims may not be used.
• Regulation (EC) No 1925/2006 — including Annex III on substances subject to prohibition, restriction or Union scrutiny.
• Regulation (EC) No 1223/2009 — cosmetic products.
• Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP) — registration, classification and labeling of chemical substances.

Poland

• Act of September 6, 2001 — Pharmaceutical Law — definition of a medicinal product and rules governing marketing authorization and advertising.
• Act of August 25, 2006 on Food and Nutrition Safety — marketing of food supplements, notification obligations and oversight by official control authorities.
• Act of April 21, 2017 on Combating Doping in Sport — legal basis for the Polish Anti-Doping Agency. Anti-doping questions are discussed separately on our page about the WADA and POLADA Prohibited List.

Seller Obligations and Restrictions

The framework above creates restrictions that are not merely precautionary; they follow from the applicable legislation.

• No medicinal claims. This follows directly from the definition by presentation: such a claim may itself change the product’s legal classification.
• No dosage or protocols for human use. A research reagent has no established dosage, and providing one would suggest use contrary to its stated purpose.
• No unauthorized health claims reserved for foods and subject to authorization.
• The material’s intended purpose must be stated unambiguously.
• The description must be accurate. Results obtained with an authorized medicinal product must not be transferred automatically to research material containing the same active substance. This issue is common with incretin analogs and requires a clear distinction.

Why Product Descriptions Are Written This Way

This section answers one of the questions most often sent to customer service: why do you not explain how to use it?

Not because we do not want to, but because no such information exists in a form we may provide. Dosage is established through the registration process: phase I studies assess tolerability, phase II studies examine dose-response relationships, and phase III studies confirm efficacy in the intended indication. Material that has not undergone this process has no authorized dosage; at most, figures circulate whose origins cannot be verified.

The consequences of this approach are visible throughout our materials:

• We distinguish animal data from human data and identify the research model. A statement that something was “demonstrated” is empty unless it says in whom or in what model.
• We state the regulatory status of each substance separately rather than applying one framework to the entire catalog. Alpha-GPC is a food ingredient assessed by EFSA, phenylpiracetam is not authorized, and Semax is a research reagent; those statements are not interchangeable.
• We explain what the data do not show. Missing evidence is as important as reported findings.
• We state anti-doping status where a substance appears on the Prohibited List.
• We do not promise outcomes. This is not because an outcome is impossible, but because a promise concerning material without registration trials cannot be supported adequately.

This approach has a cost: the texts are longer and less dramatic than competing descriptions that promise specific results. It also has an advantage: the statements can be checked. Claims about mechanism are tied to publications, while claims about legal status are tied to the legislation from which they follow.

Frequently Asked Questions

Is the Sale of Research Reagents Legal?

Trade in chemicals intended for laboratory use is governed by chemicals legislation. What is unlawful is placing on the market, without the required authorization, a product that meets the definition of a medicinal product; that definition also takes the product’s presentation into account.

Is “RUO” a Type of Approval?

No. It is a statement of intended purpose that places the material outside the marketing frameworks for products intended for human use. It is not a certification or authorization.

Does the Absence of Approval Mean a Substance Is Dangerous?

No. It means the substance has not been assessed. That is not a finding of harm, but a statement that data are lacking, which is itself an important limitation.

Does a Certificate of Analysis Change the Material’s Legal Status?

No. Analytical documentation describes the physicochemical properties of a batch and is separate from the legal basis on which the material is marketed. We explain this distinction further in How to Read a Certificate of Analysis.

Why Can the Same Substance Be a Medicinal Product in One Context and a Reagent in Another?

Because classification depends on commercial form, intended purpose and presentation, not solely on the molecule. Semaglutide supplied as a prescription medicinal product and semaglutide supplied as research material belong to different legal categories despite containing the same active substance.

Summary

A material’s legal status does not follow from the molecule alone, but from its commercial form, intended purpose and presentation. Three distinct frameworks are relevant in the European Union: medicinal-products legislation based on Directive 2001/83/EC; food and food-supplement legislation based on Directive 2002/46/EC and Regulation (EU) 2015/2283; and chemicals legislation under REACH and CLP. Research Use Only is not an approval category; it places material outside the regimes intended for products used in humans. The two-part definition of a medicinal product is decisive because it covers both pharmacological function and product presentation, while pharmaceutical legislation prevails in borderline cases. This is why an accurate research-material description contains neither human dosage nor promises of effect: such information is established through a registration process that research materials do not undergo, and providing it could itself alter the product’s legal classification.

Sources

Legislation

1. Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use.
2. Directive 2002/46/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements.
3. Regulation (EC) No 178/2002 laying down the general principles and requirements of food law.
4. Regulation (EU) 2015/2283 on novel foods.
5. Regulation (EC) No 1924/2006 on nutrition and health claims made on foods.
6. Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and certain other substances to foods.
7. Regulation (EC) No 1223/2009 on cosmetic products.
8. Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP).
9. Act of September 6, 2001 — Pharmaceutical Law.
10. Act of August 25, 2006 on Food and Nutrition Safety.
11. Act of April 21, 2017 on Combating Doping in Sport.

References

12. Van Wagoner RM, Eichner A, Bhasin S, Deuster PA, Eichner D. Chemical Composition and Labeling of Substances Marketed as Selective Androgen Receptor Modulators and Sold via the Internet. JAMA. 2017;318(20):2004–2010. PMID: 29183075
13. Cohen PA, Avula B, Wang YH, Zakharevich I, Khan I. Five Unapproved Drugs Found in Cognitive Enhancement Supplements. Neurol Clin Pract. 2021;11(3):e303–e307. PMID: 34484905
14. Barrios MM, Deconinck E, Vanhee C, et al. SARMs, Metabolic Modulators and Growth Hormone Secretagogues in Suspected Illegal Medicines, Bought as Sport Performance Enhancers. Drug Test Anal. 2025;17(10):2078–2085. PMID: 40551438
15. Jędrejko K, Catlin O, Stewart T, Anderson A, Muszyńska B, Catlin DH. Unauthorized ingredients in “nootropic” dietary supplements: A review of the history, pharmacology, prevalence, international regulations, and potential as doping agents. Drug Test Anal. 2023;15(8):803–839. PMID: 37357012
16. Zane D, Feldman PL, Sawyer T, Sobol Z, Hawes J. Development and Regulatory Challenges for Peptide Therapeutics. Int J Toxicol. 2021;40(2):108–124. PMID: 33327828
17. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026;56(8):1921–1935. PMID: 41966639