Packaging Assessment

Pursuant to 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 (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 lowest possible weight or volume of the packaging or packaging material (if the packaging for a specific product is manufactured in accordance with harmonized Czech technical standards, the requirements for the lowest weight and lowest volume of the packaging are met while complying with the requirements for 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• labeling the material from which the packaging is made, in accordance with Commission Decision No. 97/129/EC (to be repealed on August 12, 2028, by Regulation (EU) 2025/40);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 the purchaser and consumer about the method of 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 in the List of Persons Subject to the Obligation to Take Back or Recycle Packaging Waste (https://www.env.cz/www/regobaly.ns;
• maintaining records of methods for handling 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., 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 exceptions and other requirements under which persons placing packaging on the market or into circulation are not required to comply with obligations regarding take-back, recovery of packaging waste, the list of persons, and record-keeping.

PACKAGING FOR COSMETICS AND
PHARMACEUTICSPackaging for
cosmeticsRequirements for packaging for cosmetics 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 purposes 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 cosmetics. 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 preparation 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 materials for packaging production is based on the current version of the Czech Pharmacopoeia (Pharmacopoea Bohemica) and the European Pharmacopoeia, Chapter 3: Packaging and Packaging Materials, which specifies the requirements for packaging for medicinal products:

• Polyolefins (PP, PE, PP/PE)
• PVC
• PET
• Silicone elastomer and oil
• Glass packaging

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