The regulatory route, clear from the start.

The Regulatory Compass is a decision tree with seven questions. It assigns a product with Z-Chitosan to one of six categories: biocidal product, treated article, medical device, cosmetic product, food contact material or toy. Questions, answers and results are listed in the tables below. As of 26 September 2026.

• Biocidal product: Your product is likely a biocidal product under Article 3(1)(a) of the Biocidal Products Regulation (BPR). It may only be made available on the market once authorised, with its active substances approved for the relevant product type; transitional rules apply to active substances still under review, in Germany the ChemBiozidDV. The product type follows from the use, such as PT 1 human hygiene, PT 2 surface disinfection, PT 3 veterinary hygiene or PT 4 food and feed area. Advertising is governed by Article 72 BPR.
• Treated article: Your product is likely a treated article under Article 3(1)(l) BPR: it has a different main function and intentionally incorporates a biocidal product. It may only be placed on the market if all active substances it contains are approved, or listed in Annex I, for the relevant product type and use (Art. 58(2)). If a biocidal property is claimed, a label is mandatory (Art. 58(3)). On request, consumers must receive information on the treatment free of charge within 45 days (Art. 58(5)).
• Medical device: Your product is likely a medical device under Article 2(1) of Regulation (EU) 2017/745 (MDR); the Biocidal Products Regulation then gives way under its Article 2(2). The class follows from Annex VIII: a urinary catheter falls under Rule 5, class I for transient use under 60 minutes, usually class IIa for short-term use up to 30 days, and class IIb for long-term use. If the coating contains a substance that would be a medicinal product on its own and has an ancillary action, Rule 14 applies, meaning class III. Clarify this question early with your notified body.
• Cosmetic product: Your product is likely a cosmetic product under Article 2 of Regulation (EC) No 1223/2009. Before it can be placed on the market it needs a responsible person in the EU, a safety report, a product information file and notification via the CPNP. If Z-Chitosan is meant mainly to inhibit microbial growth in the product, that is, to preserve it, the substance must be listed as a preservative in Annex V. Claims must meet the common criteria of Regulation (EU) No 655/2013.
• Food contact material: Your product is a food contact material. Under Article 3 of Regulation (EC) No 1935/2004 it must not transfer constituents to food in quantities that could endanger health or bring about an unacceptable change in the food. Plastics may only use substances on the Union list in Annex I of Regulation (EU) No 10/2011; migration limits and a declaration of compliance are mandatory. Depending on where the antimicrobial property acts, the Biocidal Products Regulation or the rules on active materials also apply.
• Toy: Your product is likely covered by toy law: currently Directive 2009/48/EC, implemented in Germany by the Second Ordinance to the Product Safety Act. From 1 August 2030, Regulation (EU) 2025/2509 applies; from then on, as things stand, a toy may be neither a biocidal product nor a treated article, with a narrow exception for toys permanently installed outdoors. For developments launching after that date, an antimicrobial treatment of toys is therefore not a viable option. Playground equipment for public use is classified differently; please talk to us.
• To be clarified in a meeting: Your answers do not allow a clear classification. If your product contains no biocidal product and makes no antimicrobial claim, the Biocidal Products Regulation generally does not apply; general product rules then apply, such as the General Product Safety Regulation (EU) 2023/988. We will clarify borderline cases with you in a meeting.