Items and products which, when used for their intended purpose and in an intended way, come into direct contact with the skin and/or mucous membrane

 

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Annex XIV Of the Regulation on Health Safety of Consumer Products (‘’Official Gazette”no. 125/09 and 23/13) have been repealed.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

Condoms, baby diapers, sanitary napkins and tampons, adhesive tapes on patches, towels, paper handkerchiefs, refreshing handkerchiefs, for removing nail polish or make-up, for intimate care, skin care for incontinent persons and moistened with baby skin care oil; toilet paper, products applied to the skin and used as repellents, toothbrushes and floss, mouthpieces on diving equipment, gas (protective) masks, protective gloves, sports and other whistles, razors, nails, eyebrow care accessories, various products which are used for foot care and protection, products intended for warming the body, certain products intended for teaching in schools, jewellery and other products intended for decorating certain parts of the body, products for intimate entertainment for adults, etc.

Main requirements that the business user needs to know about

Article 60

Consumer goods from Article 59 of this Regulation (items and products which, when used for their intended purpose and in an intended way, come into direct contact with the skin and/or mucous membrane) with regard to technical requirements must conform with the standards if there are any. They can only be made using health safe materials and raw materials which do not contain ingredients harmful to human health and are permitted by recognized regulations.

Consumer goods from Article 59 of this Regulation which contain nickel and which during use come into direct and prolonged contact with the skin, must not release nickel in quantities greater than 0.5 µg/cm2/week from the parts which are in prolonged contact with the skin.

Finished products from paragraph 1 of this article must conform with the following requirements:

  1. They must not be damaged;
  2. They must be well formed in accordance with their intended use and well processed so that they do not cause injury during use and that there are no changes to the surface during the testing with appropriate model solution;
  3. Must not release dyes, heavy metals or other substances in amounts which are harmful to the health;
  4. They must cause skin irritation.

Article 61

Consumer goods from Article 59 of this Regulation made from textile, which during use come into contact with skin, including various covers, including those for seats for babies and small children, diapers and similar products, bedsheets, backpacks, wigs, artificial eyelashes, jewellery worn on the skin etc. must not be dyed with the following azo dyes: 4-aminodiphenyl, benzidine, 4-chloro-o-toluidine, 2-naphthylamine, o-aminoazotoluene, 2-amino-4-nitrotoluene, p-chloroaniline, 2,4-diaminoanisole, 4,4-diaminodiphenylmethane, 3,3´ -dichlorobenzidine, 3,3´-dimethoxybenzidine, 3,3´-dimethyl 4,4´diaminodiphenylmethane, p-cresidine, 4,4´-methylene-bis (2-chloroaniline), 4,4´-oxidianiline, 4,4 ´-thiodianiline, o-toluidine, 2,4-toluylenediamine, 2,4,5-trimethylaniline.

Article 62

The declaration of the tampon for intimate hygiene should contain a warning about the possible toxic shock syndrome.

Article 63

Wet wipes impregnated with a lotion or similar cosmetic product are subject to the requirements set out in this Regulation on cosmetic products.

Article 64

Condoms must not change their organoleptic properties (clarity, colour and odour) of the model solution by standing for one hour in a sweat model solution at 40 ° C.

In the extract with the sweat model solution Packaging from paragraph 1 of this article they must not release more than:

  • 0% zinc
  • 003% lead
  • 20μg / L of primary arylamines, expressed as aniline chloride
  • 1 mg / L secondary N-alkyl-arylamine, expressed as N-ethylphenylamine
  • 5 mg / dm2 of secondary aliphatic and cycloaliphatic amines
  • 3 μg / mL formaldehyde
  • 1 mg / kg of free zinc dibenzyldithiocarbamate, expressed as elastomer content technically unavoidable amounts of 2-mercaptobenzothiazole dithiocarbamates, thiurams and xanthates must not be proven.

 

Market Surveillance Authority

State Inspectorate

pisarnica.dirh@dirh.hr

 

Link to the TRIS database

In the TRIS database you can look up the notification of the technical rule