ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of April 1, 2026 No. 151

About modification of the Order of the Government No. 1207/2016 about approval of Sanitary regulations about cosmetic products

Based on part (2) article 6 of the Law No. 10/2009 on the state supervision of public health (The official monitor of the Republic of Moldova, 2009, No. 67, the Art. 183), with subsequent changes, DECIDES: the Government

This resolution:

- partially the Regulations (EU) shift No. 1223/2009 of the European parliament and Council of November 30, 2009 about cosmetic products (the processed edition), CELEX: 32009R1223, published in the Official magazine of the European Union by L 342 of December 22, 2009, with the last changes made by Regulations (EU) 2025/877 of the Commission of May 12, 2025;

- shifts Regulations (EU) No. 655/2013 of the Commission of July 10, 2013 about establishment of general criterions for reasons for the statements used concerning cosmetic products, CELEX: 32013R0655, published in the Official magazine of the European Union of L 190 of July 11, 2013;

- shifts the Executive decision No. 2013/674/EU of the Commission of November 25, 2013 about the guidelines concerning appendix I to Regulations (EU) No. 1223/2009 of the European parliament and Council about cosmetic products, CELEX: 32013D0674, published in the Official magazine of the European Union of L 315 of November 26, 2013.

1. In the Order of the Government No. 1207/2016 about approval of Sanitary regulations about cosmetic products (Official monitor of the Republic of Moldova, 2016, Art. No. 388-398, 1308), with subsequent changes, to make the following changes:

1.1. in formula of adoption of the resolution the text of "Article 6" to replace with the text "parts (2) Article 6";

1.2. in Regulations:

1.2.1. add Item 3 with concept:

"the harmonized standard - the standard accepted by the European body for standardization based on the inquiry sent by the European commission which application creates presumption of compliance to requirements of these Regulations";

1.2.2. add with Item 3-2 of the following content:

"3-2. The competent authority can as on own initiative, and at the request of the concerned party to take necessary measures for determination of whether the specific product or group of products falls under determination of cosmetic products according to these Regulations.";

1.2.3. state Item 7 in the following edition:

"7. Only those cosmetic products for which the responsible person - the legal entity or physical person registered in the Republic of Moldova is designated can be entered on the market.";

1.2.4. state Item 7-3 in the following edition:

"7-3. If the cosmetic product is made in the Republic of Moldova and afterwards is not exported and not reimported to the Republic of Moldova, and the producer is not registered in the Republic of Moldova, the producer the written mandate appoints the authorized representative registered in the Republic of Moldova as the responsible person, from its written consent.";

1.2.5. in the subitem 1) of Item 10 "Items 5, of 13, 15-54, 56, 58-71" to replace the text with the text "Items 5, of 6, of 13, 15-23, 25, of 26, of 27, of 29, of 30, 32-52, 55, 57-60, 63-69 and 80-3";

1.2.6. in the subitem 4) of Item 11 "within 24 hours" to replace the text with the word "immediately";

1.2.7. 2) of Item 12 to state the subitem in the following edition:

"2) the distributor identifies the distributor or the responsible person from whom the cosmetic product, and distributors to whom the cosmetic product was delivered was received;";

1.2.8. 3) of Item 16 to state the subitem in the following edition:

"3) the Report on safety of cosmetic product is supported in urgent condition taking into account any additional relevant information received after introduction of cosmetic product on the market.";

1.2.9. declare Item 17 invalid;

1.2.10. state Item 18 in the following edition:

"18. Assessment of safety of cosmetic products as it is established in Chapter II of appendix No. 2, is performed by person having the diploma or other official confirmation of qualification issued upon termination of university rate of theoretical and practical preparation in the field of pharmacology, toxicology, medicine or similar discipline, or the course of training recognized equivalent.";

1.2.11. recognize Items 18-1 and 18-2 invalid;

1.2.12. to state the name of Section 4 in the following edition:

"Section 4. Notification";

1.2.13. state Item 27 in the following edition:

"27. The preclinical researches of safety specified in assessment of the safety provided in Items 15 and 16, and the safety of cosmetic product which are carried out for the purpose of assessment shall correspond to the principles of proper laboratory practice applicable at the time of carrying out research, or to other equivalent standards recognized at the international level.";

1.2.14. declare Item 28 invalid;

1.2.15. state Item 29 in the following edition:

"29. Before introduction of cosmetic products on the market the responsible person reports to the National agency of public health by means of electronic means the following information:

1) the category of cosmetic products and its name or names allowing its individual identification;

2) the name and the address of the responsible person which provides open entry to data on products;

3) products country of source, in case of its import;

4) contact information of physical person which it is possible to contact in case of need;

5) availability of substances in the form of nanomaterials and:

a) their individualizing signs, including the chemical name and other descriptions specified in the order of the Minister of Health;

b) reasonably predictable conditions of impact;

6) the name and CAS number or the EU of the substances classified as cancerogenic, mutagen or toxic in case of reproduction (CMR) and referred to categories 1A or 1B, according to the requirements for classification, labeling and packaging of dangerous chemicals and mixes approved by the Government;

7) the final structure allowing rendering fast and appropriate medical care in hard cases.";

1.2.16. recognize Items 29-1, 31 and 31-1 invalid;

1.2.17. state Item 33 in the following edition:

"33. If any information provided in Item 29, changes, the responsible person transmits through electronic means to the National agency of public health updated information.";

1.2.18. 35, 36 and 37 to state Items in the following edition:

"35. The Ministry of Health based on regulations of the European Union claims:

1) the List of the substances prohibited to use in cosmetic products;

2) the List of substances with limited use in cosmetic products;

3) the List of the dyes permitted to use in cosmetic products;

4) the List of the preservatives permitted to use in cosmetic products;

5) the List of the UV filters permitted to use in cosmetic products.

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