Decree No. 448 / 2025 Coll.
Order on psychomodulatory substances
Valid
Order
Effective from 08.11.2025
Text versions:
08.11.2025
07.11.2025
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448
DECLARATION
of 8 October 2025
on psychomodulators
The Ministry of Health, in cooperation with the Government of the Czech Republic, provides pursuant to § 44c (7) for the implementation of § 33e paragraphs 2 and 4 and § 33f paragraphs 1 and 8 of Act No. 167 / 1998 Coll., on addictive substances and on the amendment of certain other laws, as amended by Act No. 273 / 2013 Coll., Act No. 366 / 2021 Coll. and Act No. 321 / 2024 Coll., hereinafter "the Act":
GENERAL PROVISIONS
Subject matter
This decree regulates
(a) the manner in which the data on unit packaging and external packaging of psychomodulators are presented;
(b) the manner in which the consumer information message is provided, the safety warning on the risk of the use of the product by minors and the health warning;
(c) the technical requirements for the composition, appearance, quality and properties of psychomodulatory substances, including the maximum authorised amount of psychomodulatory substance in a unit pack, the maximum authorised quantity of active substances in a unit pack, the maximum authorised concentration of active substances, the prohibited elements and features in the marketing of psychomodulators and the requirements for maximum authorised chemical and microbiological contamination;
(d) requirements for good manufacturing practice for manufacturers of psychomodulatory substances.
Definition of terms
For the purposes of this decree:
(a) the active substance, the psychoactive component of the psychomodulation agent,
(b) consumer information information communication to consumers on effects and risks and information on the recommended dosage;
(c) a safety warning on the hazard of use by minors warning information indicating the insuitability and hazard of use of psychomodulatory substances by persons under 18 years of age, both in graphic and text form;
(d) by warning health warnings, warning of harmful effects of psychomodulators on human health;
(e) distribution for placing on the market the purchase and sale of the product for resale;
(f) the manufacturing operation of premises operated by the manufacturer of psychomodulators in which the manufacture, preparation, storage and handling of unpackaged psychomodulators are produced or packaged;
(g) the operating part of the manufacturer's undertaking in which the manufacturing establishment, warehouse of packaged products or other service or office premises are located;
(h) by verifying the quality of the verification that the psychomodulatory substance meets the requirements for the maximum concentration of active substances and the requirements for the maximum permitted chemical and microbiological contamination;
(i) a product intended for placing on the market, in unit packaging, intended for placing on the market,
(j) a single dose of individually packaged or otherwise separated amount of psychomodulatory substance in a unit pack;
(k) in good manufacturing practice, a set of rules and guidelines ensuring that products intended for placing on the market comply with the legal quality and safety requirements.
TECHNICAL REQUIREMENTS
Quality and composition requirements for psychomodulators
(1) Only psychomodulatory substances which meet the quality and composition requirements set out in Annexes 1 to 6 to this Regulation may be distributed for the purpose of placing on the market or placing on the market.
(2) Products intended for placing on the market may contain only the following ingredients, in addition to active substances and constituents naturally occurring in a psychomodulation substance:
(a) additives listed in Part B of Annex II to Regulation (EU) No 1333 / 20081 of the European Parliament and of the Council;
(b) sweet2),
(c) oils, fats and
(d) solvents on an alcoholic, fat and oil basis pursuant to the implementing Regulation covering the requirements for extraction solvents used in the manufacture of foodstuffs (3);
where, at the concentration used, they do not pose a risk to human health when such products intended for placing on the market are used in accordance with consumer information, including instructions for use in accordance with Section 8.
(3) Components other than those referred to in paragraph 2 may be contained in a product intended to be placed on the market in trace quantities only if it is technically impossible to avoid the presence of that trace quantity during the manufacture of the product intended to be placed on the market.
(4) The product intended for placing on the market shall not contain constituents harmful to human health, in particular contaminating chemicals and micro-organisms; the list of chemical and microbiological indicators and their permissible values are set out in Annex 3 to this Decree.
(5) The unit packaging of a psychomodulatory substance shall not contain active substances in a concentration higher than that laid down in Annex 1 to this Decree and shall not contain a psychomodulatory substance and active substances in a quantity higher than that laid down in Annex 1 to this Decree.
(1) The psychomodulatory substance contained in the unit pack may be divided into several single doses with the same composition.
(2) Where an individual dose is provided with packaging, such packaging shall be safe for human health in accordance with the requirements of Article 3 (1) of Regulation (EC) No 1935 / 20044 of the European Parliament and of the Council, or the requirements of Article 4 (a) and (e) in the part concerning the compositional requirements of Commission Regulation (EU) No 10 / 20115, and the requirements of Article 3 (1) of the Ordinance on sanitary requirements for food and food contact products (6); the use of edible or impregnated packaging is not permitted.
Characteristics and appearance of unit packaging of psychomodulatory substance
(1) The unit packaging of a psychomodulatory substance shall be secured against any undesirable handling which would be contrary to the purpose for which the psychomodulatory substance is intended, in particular the handling of unit packaging of children, in accordance with Part 3 of Annex II to Regulation (EC) No 1272 / 20087 of the European Parliament and of the Council.
(2) The packaging of unit packs and any outer packaging must bear the name of the psychomodulatory substance, as well as its form and sub-type, as set out in Annex 2 to this Decree. The name of the psychomodulatory substance shall be given on only one line. The form designation shall be indicated on only one line and shall be indicated directly under the name of the psychomodulatory substance. The marking of the subtype shall be indicated on only one line and shall be indicated directly under the indication of the form of the psychomodulatory substance. The text containing the name of the psychomodulatory substance, or its form or subtype, shall be given in parallel with the text of the health warning. The characteristic appearance and properties of the psychomodulatory substance are listed in Annex 2 to this Decree.
(3) The external packaging containing more than one unit pack of psychomodulatory substance shall indicate the number of unit packs contained in the external packaging.
(4) If the unit pack contains single doses, the unit pack shall indicate the number of single doses. All single doses must contain the same amount of psychomodulatory substance and must have the same active substance content and the same organoleptic properties.
(5) Without dividing the contents of the unit pack into single doses, it may be adjusted to denote or define smaller parts of the psychomodulatory substance which may be used for the determination of the recommended dosage (the dosing part) when handling the unit pack normally.
(6) If the unit pack contains a psychomodulatory substance of liquid consistency, it shall be provided with a dropper or other dosing mechanism which, when handling the unit pack, allows the recommended single dose to be safely determined while preventing the unit pack from being emptied at the same time.
Unit packaging designation
(1) Where the packaging of the unit pack and the outer packaging is marked with the name of the trade mark, that name shall be indicated on only one line.
(2) The packaging of a unit pack and the outer packaging of a psychomodulatory substance may be accompanied by a barcode or a QR code once, provided that such code:
(a) is black on white background; and
(b) does not represent a image, a pattern or symbol similar to anything other than a barcode or a QR code;
contain information for consumers, shall not supplement, amend, comment or paraphrase information for consumers in accordance with Article 8 (1).
(1) Information pursuant to § 33e (1) of the Act
(a) they must be indicated on, or attached to, unit and outer packaging;
(b) be visible, easily legible and indelible;
(c) they must not be covered or interrupted when distributed for marketing or marketed; and
(d) must be in the Czech language for text information.
(2) The net amount of psychomodulatory substance in unit pack and per dose, if the unit pack contains single doses, should be given in milligrams (mg) or grams (g) for powder, solid or semi-solid consistency or in millilitres (ml) for liquid consistency substances.
(3) The concentration of active substances in the psychomodulatory substance shall be given as a percentage by weight of the net mass of the psychomodulatory substance using the symbol "% '. If the concentration of the active substance exceeds 1,0%, it can be given in whole numbers. The concentration of the active substance may be stated within a range which includes the actual concentration of the active substance and which does not exceed a third of the mean of that range by its range.
(4) The ingredients referred to in Article 3 (2) contained in a psychomodulatory substance must be listed in descending order of weight.
(1) Each unit pack and any outer packaging of a psychomodulatory substance must be provided with information for the consumer consisting of:
(a) the title as amended by "Consumer Information,"
(b) the text of the consumer information message as set out in Annex 4 to this Decree;
(c) instructions for use under the Consumer Protection Act (8), which shall include a description of the method of use of the product; and
(d) information on the recommended dosage, which means information on the value of the recommended single dose of the psychomodulant substance and the recommended daily dose of the psychomodulant substance, depending on how the product is used.
(2) The heading referred to in paragraph 1 (a) is given in greater or more visible letters than the other text of the consumer information.
(3) The instructions for use referred to in paragraph 1 (c) shall be given by the heading "Instructions for use ', which shall be placed immediately below the text of the consumer information. The instructions for use shall contain a description of the method of use of the product from which it must be apparent how the product should be prepared for use and how the psychomodulatory substance should be used. The instructions for use referred to in paragraph 1 (c) shall also include instructions for the storage and storage of the psychomodulatory substance.
(4) Instructions for use referred to in paragraph 1 (c) shall not contain instructions to guide the consumer:
(a) smoking;
(b) transdermal use,
(c) for use in such a way as to impair the integrity of the skin or mucous membranes;
(d) for inhalation of non-burning aerosol if the psychomodulatory substance contains oils or fats.
(5) The recommended dosage value referred to in paragraph 1 (d) shall be given in milligrams (mg) or grams (g) for powder, solid or semi-solid consistency or in millilitres (ml) for liquid consistency substances. The recommended dosage can be given in the number of units of tablespoons, teaspoons or droplets if the pack is provided with the appropriate dosing mechanism, when the recommended dose is converted into their unit volume, the unit volume of the tablespoon being set at 17 ml, the unit volume of the teaspoon being set at 7 ml and the unit volume of the droplet being set at 0,05 ml. The recommended dosage can be given in the number of single doses of the psychomodulator substance if the unit pack contains single doses. The recommended dosage can be given in the dosing parts if the contents of the unit pack are provided with the dosing parts.
(6) The recommended dosage must not exceed the value representing the amount of the psychomodulatory substance that contains the maximum authorised single dose of the active substance for the recommended single dose of the psychomodulator and the maximum authorised daily dose of the active substance for the recommended daily dose. The maximum authorised single doses and maximum authorised daily doses of active substances are set out in Annex 5 to this Decree.
The instructions for use referred to in Article 8 (1) (c) and the information on the recommended dosage referred to in Article 8 (1) (d) shall not detract, supplement, amend, comment or paraphrase the text of the information for consumers under Article 8 (1) (a) and (b).
(1) The consumer information referred to in Article 8 (1) or the packaging of a psychomodulatory substance must not contain any additional text or graphic element which would in any way detract, supplement, amend, amend, comment, paraphrase or refer to such text or graphic element.
(2) The consumer information referred to in Article 8 (1) may appear directly on the packaging, on the label or by other means, but must always be included in the unit pack; where it is indicated on the label, the label shall be adhesive, adhesive, laminated or sandwich.
(1) A code number of 8 digits shall be used to indicate the lot.
(2) Before the lot designation, the letter "L 'shall be given, except where this is clearly distinguishable from other indications and there is no possibility of confusion with other indications.
(3) The lot marking shall be easily visible, clearly legible and indelible.
(1) The safety warning on the danger of the use of the product by minors under Paragraph 33e (1) (n) of the Act is a graphic mark together with the text "Not addressed to persons under 18 years of age." and "Save out of reach of persons under 18 years of age." the image form of the graphic mark is given in Annex 6 to this Decree; the text of the safety warning shall be placed in the immediate vicinity of the graphic mark and shall be placed on a white background; no additional text or graphic item may be indicated on the packaging that would in any way deter, comment, paraphrase or refer to such text or graphic item.
(2) The health warning under § 33e (1) (o) of the Act reads: "Taking this product may harm your health. Take care of consumer information. '; no additional text or graphic item can be indicated on the packaging that would in any way deter, comment, paraphrase or refer to such text or graphic item.
(3) Information on the presence of substances which may cause allergies or intolerance in certain persons under Section 33e (1) (n) of the Act is understood as referred to in Article 9 (1) (c) of Regulation (EU) No 1169 / 20119 of the European Parliament and of the Council.
The health warning referred to in Article 12 (2) shall:
(a) be printed in black in bold Helvetica, with the default character interpolation setting, which is 100% scale and spaces normal, on white background; point font size must be such that the text concerned occupies as much of the surface reserved for it as possible;
(b) be placed at the centre of the surface reserved for them;
(c) be placed parallel to the main text on the area reserved for this warning;
(d) be parallel to the side edge of the unit pack or outer packaging;
(e) be indicated on the largest surface area of the unit pack and any outer packaging;
(f) cover at least 30% of the surface area of the largest surface area of the unit pack and any outer packaging on which the health warning is printed; and
(g) in the usual way of opening the unit pack, remain undisturbed.
Prohibited elements and features
(1) Any packaging of a psychomodulatory substance, the content of a unit pack of a psychomodulatory substance or the form of a single dose, the labelling or presentation of a psychomodulatory substance shall not contain any element or feature which:
(a) promote or promote the consumption of a psychomodulation substance with reference to its properties and health effects;
(b) suggests that the psychomodulatory substance has vitalisation, energizing, healing, rejuvenating or natural effects or properties of organic farming products or other health or lifestyle benefits;
(c) states that the psychomodulation substance does not contain any additives or flavourings;
(d) promote naturally occurring substances or additives with reference to their properties and health effects.
(2) Any packaging of a psychomodulatory substance, the contents of a unit pack of a psychomodulatory substance or the appearance of a single dose, labelling or presentation of a psychomodulator substance must not:
(a) indicate economic advantages, including through printed vouchers, discount offers, free distribution, two-for-one offers, or other similar offers,
(b) encourage the use of a psychoactive substance which represents an increase in health or other risks of its use;
(c) contain any elements typical of substances the placing on the market of which is prohibited or elements promoting socially undesirable behaviour;
(d) indicate an increased possibility of achieving personal or social success;
(e) contain any elements which may be particularly attractive to persons under 18 or which directly or indirectly target persons under 18 or which are based on a culture of persons under 18;
(f) contain other flavourings and flavourings other than those in the form of text which is indicated by the word "flavour."
(3) Any display, in particular text, symbol, name, trade mark, figurative or other character, shall be an element or feature prohibited under paragraphs 1 and 2.
(4) A single dose of a psychomodulatory substance intended for oral use, having semi-rigid or semi-rigid consistency, shall be in a neutral form in the form of a simple geometric unit.
Technical requirements for batch quality verification of psychomodulatory substance
The manufacturer or distributor of psychomodulators shall verify the quality of the batch of psychomodulators intended for placing on the market in accordance with the technical requirements set out in Annex 7 to this Decree.
ADMINISTRATIVE PRODUCTION PRACTICE
Requirements for good manufacturing practice
Requirements for good manufacturing practice include:
(a) rules governing the management of the quality management system;
(b) principles of operational and personal hygiene;
(c) requirements for manufacturing operations;
(d) requirements for production facilities;
(e) requirements for production processes and technologies;
(f) rules on documentation management;
(g) packaging requirements;
(h) storage requirements; and
(i) requirements for the management of production waste.
Quality management system
(1) The manufacturer shall, in the framework of production, proceed to ensure that the resulting product complies with the quality requirements of the psychomodulatory substance set out in Part Two of this Ordinance.
(2) In order to achieve the required quality of the psychomodulatory substances intended for placing on the market, the manufacturer shall establish and put into practice, through internal regulations, a quality assurance system which complies with the minimum requirements for good manufacturing practice laid down in this Decree. The manufacturer shall monitor the effectiveness of the quality assurance system on a continuous basis, make and maintain records of the monitoring and, in the event of deficiencies detected, amend or update the system.
(3) The quality assurance system shall include repeated internal controls to monitor compliance with good manufacturing practice rules and to enable corrective action to be taken subsequently if necessary. The manufacturer shall keep and keep records of such internal controls and any corrective measures subsequently taken for at least 5 years.
Principles of operational and personal hygiene
(1) All persons working in production operations in places where psychomodulatory substances are handled must respect the principles of personal hygiene, at least
(a) maintain sanitary facilities, such as dressing rooms, washrooms, showers and toilets, and auxiliary facilities such as work footwear washing facilities, drying of work clothes, heating rooms, rest rooms, first aid facilities and storage facilities for cleaning products and their equipment, clean and operational,
(b) not to retain articles other than those relating to the performance of work in production operations;
(c) not to allow unauthorised persons to enter production operations;
(d) to put away personal goods, civil clothing and footwear only in the dressing room or in the reserved area of the manufacturing establishment outside the production operation;
(e) for cleaning, use only cleaning, cleaning and disinfection products intended for the food industry;
(f) not to smoke or use other aerosols by inhalation in production;
(g) store cleaning products and preparations for routine protective disinfection, disinsection and extermination in original packaging out of production; and
(h) not to use containers and packaging intended for psychomodulatory substances or foodstuffs for the storage of cleaning products and preparations for routine protective disinfection, disinsectisation and exertification.
(2) These principles of personal hygiene apply to persons working in manufacturing operations in places where psychomodulators are treated
(a) to take care of body cleanliness and before starting their own work, when switching from unclean work to clean work, after using a toilet, after handling the waste and at each pollution wash their hands in warm water using a suitable detergent or disinfectant;
(b) wear clean personal protective equipment appropriate to the nature of the activity, in particular working clothing, work footwear and headgear in the manufacture of psychomodulators; keep the working clothing clean and exchange it as necessary during shift, during work activities requiring a high degree of purity, or use disposable protective gloves and mouthwash at a higher risk of contamination,
(c) not to leave production operations during working time in work clothing and in work footwear;
(d) exclude any non-sanitary behaviour in production operations;
(e) ensure the care of hands, nails on hands to have cut short, clean, without painting, on hands not to wear decorative or other objects; and
(f) to store used working clothes, as well as civil clothing in a place reserved for that purpose outside the production operation; to store working clothes and civil clothing separately.
(3) The manufacturer of psychomodulatory substances shall ensure that on any section where psychomodulatory substances are treated, a person who is suffering from a disease or is a carrier of a disease that can be transmitted by food or is particularly affected by infected injuries, skin infections, ulcers or diarrhoea. This applies to any classification in the performance of which the possibility of direct or indirect contamination of psychomodulatory substances by pathogenic micro-organisms arises.
Production operation
(1) In production operations:
(a) floor surfaces shall be kept in impeccable condition and shall be easily cleaned and, if necessary to ensure operational hygiene, easily disinfected; durable, non-aqueous, washable, non-slip and non-toxic materials shall be used; where necessary in order to ensure operational hygiene, the floors shall be such that water is removed from the surface;
(b) the walls are maintained in impeccable condition and must be easily cleaned and, if necessary to ensure operational hygiene, easily disinfected; durable, non-waterproof, washable and non-toxic materials and smooth surfaces shall be used up to a height corresponding to operating operations;
(c) ceilings and ceilings designed, constructed and equipped with a final treatment to prevent the accumulation of impurities and to reduce condensation, growth of undesirable moulds and separation of particles;
(d) windows and other openings designed to prevent the accumulation of impurities; windows and openings which are open to the external environment shall, if necessary to ensure operational hygiene, be equipped with insect nets which can be easily removed during cleaning; if contamination of psychomodulatory substances is likely to occur through open windows, the windows shall remain closed and secured during manufacture;
(e) easy-to-clean doors and, if necessary to ensure operational hygiene, easily disinfected; smooth and non-wet surfaces shall be used;
(f) surfaces, including those of the production facility, which come into contact with psychomodulatory substances, are maintained in impeccable condition and are easy to clean, and, if necessary to ensure operational hygiene, easily disinfected; Smooth, washable and non-toxic materials shall be used.
(2) If necessary to ensure operational hygiene, accessories for cleaning and disinfection of working tools and production facilities shall be available. These accessories shall be designed from corrosion resistant materials and shall be easy to clean, with a supply of hot and cold drinking water.
(3) The separate washing of psychomodulators must be ensured so that the washing of the psychomodulator does not involve water washing with already washed psychomodulators. Each effluent or other such device intended for washing psychomodulators shall have a supply of hot or cold drinking water and shall be kept clean.
Production equipment
All manufacturing equipment with which the psychomodulatory substance comes into contact shall be kept clean,
(a) constructed in such a way, from such materials as are safe for contact with food and maintained in such order and good technical condition that the risk of contamination of the psychomodulatory substance is minimised;
(b) with the exception of disposable packaging, constructed in such a way, of such materials and maintained in such order and good technical condition as to enable them to be thoroughly cleaned and, if necessary to ensure operational hygiene, their disinfection; and
(c) installed in such a way as to allow adequate cleaning of the surrounding areas.
Production processes and technologies
(1) Only the extraction solvents listed in the Decree governing the requirements for extraction solvents used in the manufacture of food 10 may be used for the extraction of the active substance.
(2) In the manufacture of a psychomodulatory substance intended for oral administration, only the ingredients referred to in § 3 (2) may be used in addition to the psychomodulatory substance.
(3) The ingredients referred to in Article 3 (2) (a) and (c) may be added to the psychomodulatory substance if their addition increases the safety of the product intended for placing on the market or if technically necessary.
Documentation
(1) The manufacturer shall ensure that all activities related to the production and processing of psychomodulators and the disposal of waste generated during manufacture are recorded.
(2) The manufacturer shall establish, maintain and regularly update a system of controlled documentation governing the manner and extent of the implementation of the protocol and record keeping of activities related to the manufacture and processing of psychomodulators and the disposal of waste generated in the manufacture and maintenance of other records. The manufacturer shall establish a clear and understandable system that does not raise doubts as to which specific persons are required to carry out the protocol and keep records.
(3) Records of specific activities shall be recorded immediately after the activity concerned has been carried out in such a way that each individual activity can be traced back.
(4) All documents relating to the manufacture and processing of psychomodulatory substances and the disposal of waste generated in production shall be kept in paper or electronic form for at least 5 years from the receipt of the document or, where applicable, from the last entry therein, whichever is the later. The documentation shall be kept in such a way as to prevent the destruction, loss, damage, destruction, misuse or theft of documents, while allowing for the immediate presentation of documents to the inspection authorities.
(5) At least the following information shall be documented:
(a) the name and, where appropriate, the names and surname or name of the manufacturer;
(b) the place of manufacture, the address and the identification of the room,
(c) the lot number,
(d) the type, origin and quantity of the initial psychomodulatory substance or any other substance which is not a psychomodulatory substance but is the main feedstock for its production and the treatment of which results from a psychomodulatory substance;
(e) the conditions of manufacture;
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Regulation Information
| Citation | Decree No. 448 / 2025 Coll., on psychomodulatory substances |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 07.11.2025 |
|---|---|
| Effective from | 08.11.2025 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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