Liability and research use

This policy applies to every order placed with PulseChem SRL and to the use of this website, alongside our terms and conditions and the RUO policy. You expressly accept it at checkout. With each order we record when you accepted it and which version of this policy applied at that time.

We sell peptides and other research chemicals, as well as supplies for work in the laboratory. They are intended for in vitro laboratory research: measurements in a test tube, in cell culture or on isolated material, carried out by or under the supervision of people trained to do so.

Every batch comes with a certificate of analysis (COA) from an external laboratory, stating purity by HPLC and identity by mass spectrometry (see our laboratory standard). The certificate describes the chemical quality of the batch. It says nothing about safety or effects in humans or animals, and it is not intended to.

• Not authorised medicinal products. They hold no marketing authorisation as a medicinal product, we do not offer them as medicinal products, and they are not intended to diagnose, treat, cure or prevent any disease. Whether a substance is a medicinal product in law is ultimately decided by the competent authority (see section 6).
• Not intended as medical devices, foods, food supplements or cosmetic products.
• Not intended for use in, or administration to, humans or animals in any form.
• Not evaluated by the EMA, the ANMDMR (the National Agency for Medicines and Medical Devices of Romania) or the FDA.

The EU definition is set out in Article 1(2) of Directive 2001/83/EC. A substance is a medicinal product if it meets at least one of two criteria:

• By presentation: it is presented as having properties for treating or preventing disease in human beings (Article 1(2)(a)).
• By function: it may be used in or administered to human beings either to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, or to make a medical diagnosis (Article 1(2)(b)).

Where, in cases of doubt, a product may fall both within this definition and within the definition of a product covered by other rules, the medicines legislation applies (Article 2(2)). The Member States have adopted the definition, for example Romania in Title XVIII “Medicamentul” of Law No. 95/2006 (Article 699, point 1, in the republished text of 2015), the Netherlands in Article 1(1)(b) of the Geneesmiddelenwet (Medicines Act) and Germany in Section 2(1) of the Arzneimittelgesetz (Medicinal Products Act).

The Court of Justice of the European Union interprets the two criteria as follows:

• Presentation is construed broadly. A product is presented as a medicinal product not only when it is expressly described or recommended as such, but also whenever an averagely well-informed consumer gains the impression, even by implication, that it has such properties (Van Bennekom, C-227/82).
• Function is assessed product by product. The national authorities decide case by case, subject to review by the courts, taking account of all the characteristics of the product: its composition, its pharmacological, immunological or metabolic properties as established by current scientific knowledge, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks its use may entail (Upjohn, C-112/89; HLH Warenvertrieb and Orthica, C-211/03; Hecht-Pharma, C-140/07). A substance is a medicinal product by function only if it is capable of appreciably restoring, correcting or modifying physiological functions (Hecht-Pharma).

We offer the products as research chemicals, not as medicinal products:

• Every product states that it is intended exclusively for in vitro laboratory research and not for human or animal use (Research Use Only).
• We make no health claims and give no dosing, administration schedules, instructions for use or testimonials, not even on request.
• Product pages and the knowledge base are limited to chemical data, storage and handling in the laboratory, and what has been published in the scientific literature, with sources.
• On your first visit, the website asks whether you are 18 or older and whether you are a researcher or are buying for research.
• With every order you confirm that the products are for in vitro laboratory research only, accept this policy and declare that you are 18 or older.
• We block an account and stop deliveries if there are signs that products are not being used for research or are being resold to private individuals.

In this way we address the presentation criterion: nothing in our offer may give the impression that a product is a means of treating or preventing disease.

Whether a given substance counts as a medicinal product in a given country is ultimately decided by that country’s competent authority, subject to review by the courts. We cannot make that decision, and we do not claim that an authority will never classify a substance as a medicinal product. A substance with a pharmacological action can be a medicinal product by function however it is offered. Offering it as a research chemical is therefore not enough on its own: what happens to a product after delivery also counts. Anyone who offers or uses a substance for administration to humans may themselves fall under the medicines legislation, whatever the label says (see also RUO explained).

Some peptides are also the active substance of an authorised medicinal product. Our product is not that medicinal product: it does not have its authorisation, its manufacturing requirements or its documentation, and it is not a substitute for it.

Chemicals: REACH

As chemical substances, the products fall under Regulation (EC) No 1907/2006 (REACH). REACH defines scientific research and development as scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume of less than one tonne per year (Article 3(23)). Registration is required only from one tonne per year per manufacturer or importer (Article 6(1)). For scientific research and development, the authorisation requirement (Article 56(3)) and the restrictions in Annex XVII (Article 67(1)) do not apply. REACH does not decide whether a substance is a medicinal product; the medicines legislation does.

Product safety

Regulation (EU) 2023/988 on general product safety has applied since 13 December 2024 to products intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers (Article 3(1)). Medicinal products are excluded (Article 2(2)(a)). Because private individuals can also order from us, every product carries the warning that it is for laboratory research only and not for use in humans or animals. That warning is there for your safety: follow it.

By placing an order, you declare that:

• you are 18 or older (see Age and ID check);
• you will use the products exclusively for in vitro laboratory research, carried out by or under the supervision of people trained to do so;
• you will not administer the products to humans or animals, will not ingest them and will not use them as a medicinal product, food supplement or cosmetic product;
• you will not sell or supply the products to private individuals, or to anyone you know or may suspect will not use them for research;
• you have checked that buying, importing, possessing and using the products is permitted in your country, and that you hold any licences this requires;
• the information you provide with your order is correct and complete.

• Storage: store the products as stated on the label and the certificate of analysis, in the closed packaging and out of the reach of children and unauthorised persons.
• Handling: follow the safety rules that apply to chemicals in your laboratory, with the appropriate protective equipment.
• Waste: dispose of residues and packaging in accordance with the rules for laboratory waste.
• Documentation: record the batch number in your lab notebook so that you can find the matching certificate on the Lab results page.
• Legislation: comply with the rules that apply to your research and in your country.

Any use that is not in vitro laboratory research is misuse, as is resale or supply for such use. Where there are signs of misuse, we may refuse orders, and we stop deliveries and block the account.

Anyone who misuses a product does so on their own responsibility and at their own risk. You indemnify PulseChem SRL against claims by others and against damage and costs resulting from use, resale or supply by you in breach of this policy or of the law, to the extent permitted by law.

To the extent permitted by law:

• We are not liable for damage arising because a product is used other than for in vitro laboratory research, or in breach of this policy, the label or the law.
• We are not liable for indirect damage, such as loss of profit or failed experiments.
• In all other cases, our liability is limited to the invoice amount of the order to which it relates, as set out in clause 9 of our terms and conditions.

What we do not exclude

Some liability cannot be excluded or limited by law. The limitations above therefore do not apply:

• in the event of intent or gross negligence on our part (Article 1355(1) of the Romanian Civil Code, the Codul civil);
• to death or personal injury caused by our act or omission. Under Romanian law, liability for harm to physical or mental integrity or to health can only be excluded or reduced under the conditions laid down by law (Article 1355(3) of the Codul civil). The EU directive on unfair terms includes a term that does this towards a consumer in its list of terms which may be regarded as unfair (Directive 93/13/EEC, Article 3(3) and Annex, point 1(a); transposed in Romania by Law No. 193/2000);
• to our liability as producer for damage caused by a defective product. Anyone who, by putting their name, trade mark or other distinguishing feature on a product, presents themselves as its producer counts as its producer (Article 3(1) of Directive 85/374/EEC; Court of Justice, Fennia, C-264/21). That liability cannot be limited or excluded by contract in relation to the injured person (Article 12 of that directive; for products placed on the market or put into service after 8 December 2026, Article 15 of Directive (EU) 2024/2853, see Article 2(1) as corrected on 7 May 2026). In Romania, the 1985 directive was transposed by Law No. 240/2004;
• to the rights you have as a consumer under mandatory law. If you are a consumer in a country to which we direct our sales, you also keep the protection of the mandatory rules of the country where you have your habitual residence (Article 6(2) of Regulation (EC) No 593/2008, Rome I).

Whether a product is defective depends on the safety a person is entitled to expect. This takes into account, among other things, how the product is presented and the use to which it could reasonably be expected to be put (Article 6(1) of Directive 85/374/EEC). The new directive refers to reasonably foreseeable use (Article 7 of Directive (EU) 2024/2853). A warning therefore counts, but it does not automatically exclude liability. Where the damage is caused partly by the fault of the injured person, for example by use contrary to the warnings, liability may be reduced or disallowed (Article 8(2) of Directive 85/374/EEC; Article 13 of Directive (EU) 2024/2853).

The information on this website, in our emails and in the chat is intended as documentation for laboratory research. It is not medical, pharmaceutical, legal or any other advice. A summary of published research is not a promise that a substance does anything, and it says nothing about safety or effects in humans or animals. We do not answer questions about use in humans or animals, not even on request. We compile the information with care, but we cannot guarantee that it is complete or that the published literature is correct.

We may change this policy, for example when the law changes. An order is governed by the version you accepted when you placed it.

This policy is issued by:

PulseChem SRL
București
Romania

You can email questions about this policy to [email protected] or send them through the contact page. If you are unsure whether your research falls within this policy, ask us beforehand.

This policy has been prepared carefully on the basis of the sources below, but it is not legal advice to you. What applies in your situation depends on the law of your country and on the facts.

The legal texts and judgments were consulted in November 2026.

• Directive 2001/83/EC on the Community code relating to medicinal products for human use, Article 1(2) and Article 2(2) (EUR-Lex, with consolidated versions)
• Court of Justice, 30 November 1983, Van Bennekom, C-227/82 (EUR-Lex)
• Court of Justice, 16 April 1991, Upjohn, C-112/89 (EUR-Lex)
• Court of Justice, 9 June 2005, HLH Warenvertrieb and Orthica, C-211/03 and others (EUR-Lex)
• Court of Justice, 15 January 2009, Hecht-Pharma, C-140/07 (EUR-Lex)
• Law No. 95/2006 on healthcare reform (Legea nr. 95/2006 privind reforma în domeniul sănătății), republished in Monitorul Oficial No. 652 of 28 August 2015, Title XVIII “Medicamentul”, Article 699, point 1 (Portal Legislativ of the Romanian Ministry of Justice)
• Geneesmiddelenwet (Dutch Medicines Act), Article 1(1)(b) (wetten.overheid.nl)
• Arzneimittelgesetz (German Medicinal Products Act), Section 2 (gesetze-im-internet.de, German Federal Ministry of Justice)
• Regulation (EC) No 1907/2006 (REACH), Article 3(23), Article 6(1), Article 56(3) and Article 67(1) (EUR-Lex)
• Regulation (EU) 2023/988 on general product safety, Article 2(2) and Article 3(1) (EUR-Lex)
• Directive 85/374/EEC concerning liability for defective products, Article 3(1), Article 6(1), Article 8(2) and Article 12 (EUR-Lex)
• Court of Justice, 7 July 2022, Fennia, C-264/21 (EUR-Lex)
• Directive (EU) 2024/2853 on liability for defective products, Article 2(1) and Articles 7, 13 and 15 (EUR-Lex)
• Corrigendum to Directive (EU) 2024/2853, OJ L 2026/90364 of 7 May 2026: in Article 2(1), 9 December 2026 is replaced by 8 December 2026 (EUR-Lex)
• Directive 93/13/EEC on unfair terms in consumer contracts, Article 3(3) and Annex, point 1(a) (EUR-Lex)
• Regulation (EC) No 593/2008 (Rome I), Article 6(2) (EUR-Lex)
• Romanian Civil Code (Codul civil, Law No. 287/2009), republished in Monitorul Oficial No. 505 of 15 July 2011, Article 1355; Law No. 240/2004 on producers’ liability for damage caused by defective products; Law No. 193/2000 on unfair terms in contracts with consumers (Portal Legislativ)