Packaging Evaluation

Regulation (EU) 2025/40 of the European Parliament and of the Council of December 19, 2024 , on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC (OJ L, 2025/40, Jan. 22, 2025 ).

This Regulation entered into force in February 2025, and its binding rules and initial obligations take effect on August 12, 2026 . For details, see:

Packaging and Packaging Waste under the PPWR Regulation—

Placing Packaging, Packaged Products, or Packaging Materials on the Market by August 12, 2026

Under the Packaging Act No. 477/2001 Coll. , a person who places packaging, a packaged product, or a packaging material on the market must ensure:

• the minimum concentration of heavy metals and other hazardous substances*) in the packaging, packaged product, or packaging material in accordance with the limit values set forth in legal regulations**);
• the sum of the amounts of lead, cadmium, mercury, and chromium with an oxidation state of VI in the packaging or packaging material must not exceed 100 micrograms/g (this does not apply to crystal glass packaging);
• the reusability of packaging residues or packaging materials after their intended use or removal of the product, either through recycling, energy recovery, or organic recycling;
• reduction of packaging waste by ensuring the packaging or packaging material has the lowest possible weight or volume, (if the packaging for a specific product is manufactured in accordance with harmonized Czech technical standards, the requirements for minimum weight and minimum volume of the packaging are met while complying with the requirements imposed on the packaged product);
• labeling the material from which the packaging is made, in accordance with Commission Decision No. 97/129/EC (to be repealed on August 12, 2028, by Regulation (EU) 2025/40);
• informing customers and consumers about the method for ensuring the take-back of packaging or packaging materials;
• take-back of such packaging or waste from such packaging;
• submission of an application for entry into the Register of Persons Subject to the Obligation to Take Back or Recycle Packaging Waste (https://www.env.cz/www/regobaly.ns);
• maintaining records of the methods used to handle packaging and packaging waste, and retaining documents containing the data recorded in these records and reported from these records for a period of at least 5 years;
• demonstrating to the supervisory authorities compliance with the obligations under Act No. 477/2001 Coll.;
• maintaining technical documentation, which must be submitted upon request by supervisory authorities and which demonstrates compliance with the requirements of technical standards.

*) Table 3.2 of Part 3 of Annex VI to Regulation (EC) No. 1272/2008 of the European Parliament and of the Council on the classification, labeling, and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No. 1907/2006, as amended.

**) e.g., the Air Protection Act No. 201/2012 Coll., the Water Act No. 254/2001 Coll., and the Waste Act No. 185/2001 Coll. (The Waste Act No. 185/2001 Coll. was replaced by Act No. 541/2020 Coll.)

The Packaging Act No. 477/2001 Coll. specifies exemptions and other requirements under which persons placing packaging on the market or into circulation are not required to comply with obligations regarding take-back, recycling of packaging waste, the list of persons, and record-keeping.

Cosmetics Packaging:

Requirements for cosmetics packaging are set forth in Regulation (EU) No. 1223/2009 of the European Parliament and of the Council on cosmetic products (consolidated version in PDF format as of May 1, 2025). Annex I to Regulation (EU) No. 1223/2009 of the European Parliament and of the Council—the Cosmetic Product Safety Report— contains requirements regarding impurities, trace amounts of prohibited substances, and information on packaging materials. The most important properties of packaging materials for cosmetic products are, in particular, purity and stability. However, Regulation (EU) No. 1223/2009 of the European Parliament and of the Council does not specify specific requirements for packaging intended for cosmetic products. Regulation (EC) No. 1935/2004 may also apply to cosmetic packaging, but demonstrating compliance with Regulation (EC) No. 1935/2004 is not always sufficient.

Pharmaceutical packaging:

In the case of packaging

for

human medicinal products and packaging for raw materials used in the manufacture of human medicinal products, the supervisory authority designated by the Packaging Act is the SÚKL (State Institute for Drug Control). The evaluation of packaging and packaging materials is conducted in accordance with the current edition of the Czech Pharmacopoeia (Pharmacopoea Bohemica) and the European Pharmacopoeia, Chapter 3: Packaging and Packaging Materials, which specifies the requirements for pharmaceutical packaging:

• Polyolefins (PP, PE, PP/PE),
• PVC,
• PET,
• silicone elastomer and oil,
• glass packaging

. The 2023 Czech Pharmacopoeia and its supplements are available on the SÚKL website .