Consumer goods packaging
National legislation
Regulation on Health Safety of Consumer Products
Official Gazette, No. 125/2009, 43/2010, 23/2013 and 90/2013
- on the day of accession of the Republic of Croatia to the European Union, provisions of article 3, point 4 and articles 19 and 24 of the Regulation of Health Safety of Consumer Products (‘’Official Gazette” no. 125) will expire in the part pertaining to the special use cosmetics, and chapter IV “BORDERLINE PRODUCTS BETWEEN COSMETICS AND MEDICINAL PRODUCTS” and Annex XII “PERMITTED HERBAL SPECIES FOR SPECIAL USE COSMETICS (INCI nomenclature) of the said Regulation and Article 7 through 18.j and Annex I through XII and Annex XIV,
- article 1 Of the Regulation on Abrogation of Certain Provisions of the Health Safety Regulation (‘’Official Gazette” no. 90/13), articles 7 through 18.j and Annex I through XII and Annex XIV Of the Regulation on Health Safety of Consumer Products (‘’Official Gazette”no. 125/09 and 23/13) have been repealed.
Competent authority
Ministry of Health
Email: helpdesk.predmeti_opce_uporabe@miz.hr
Phone: +385 1 46 07 555
Web: https://zdravlje.gov.hr/
Scope of application
packaging in which consumer goods are packaged
Main requirements that the business user needs to know about
Article 23
By packaging within the meaning of this Regulation we refer to packaging in which consumer goods from Article 3 of this Regulation are packaged.
Article 24
Special requirements with regard to health safety prescribed by this Regulation pertain to packaging which comes into direct contact with cosmetic products, certain items and substances which during use come into direct contact with the skin or mucous membrane and special use cosmetics.
Article 25
Packaging from Article 23 of this Regulation must be made from materials which do not have adverse effect on the organoleptic, chemical or physical properties of consumer goods with they are in direct contact, do not contain or release substances which could be harmful to the health or in quantities harmful to the health and do not have an adverse effect on maintaining the consumer goods in health safe condition. Dyes and fillers used in the manufacture of packaging must be health safe.
Article 26
Packaging from Article 23 of this Regulation made from polymer materials must meet the following requirements:
1. global migration to distilled water and 3% (v/v) acetic acid over the course of 10 days at the temperature of 40°C must not be greater than 10 mg/dm2;
2. Specific migration of primary aromatic amines must not be greater than 0.02 mg/dm2, expressed as aniline;
3. Specific migration of residual peroxides must not be greater than 0.5 mg/dm2, expressed as active oxygen;
4. Specific migration of heavy metals, expressed per litter of model solution (3% (v/v) acetic acid) must not be greater than:
- 0.5 mg/L of lead
- 0.05 mg/L of cadmium
- 0.01 mg/L of mercury.
- 0.1 mg/L of arsenic,
- 0.1 mg/L of chromium,
- 50 mg of zinc.
5. if painted, it must not release dyes.
Article 27
Aluminium i.e. aluminium alloy used for making packaging for products from Article 24 of this Regulation must conform with the requirements of the European standard on the purity of food packaging materials and must be coated with protective varnish i.e. protect with foil made from health safe polymer material.
Article 28
Packaging from Article 23 of this Regulation made from glass must meet the following requirements:
1. must be made from homogenous glass material;
2. Glass wool must not be used in making it;
3. Surface of the inside of the glass packaging must be smooth, and the top edge of the opening must not be sharp or damaged;
4. after standing in acetic acid, 4% (v/v) during 24 hours at the temperature of 22 ± 2°C, expressed for 1L, must not release:
- more than 0.05 g of lead;
- more than 0.005 mg of cadmium;
Glass packaging whose glass material turned opaque (matt) after an 1 hour sterilization experiment carried out at the temperature of 121°C is prohibited.
Market Surveillance Authority
State Inspectorate
Link to the TRIS database
In the TRIS database you can look up the notification of the technical rule