G/TBT/N/DOM/233  
13 February  2023 
(23-1008) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member : DOMINICAN REPUBLIC  
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Ministerio de Salud Pública y Asistencia Social  (Ministry of Public Health and Social 
Welfare)  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle commen ts 
regarding the notification shall be indicated if different from above:  
Ms Anel Payero González, as Legal Coordinator of the Directorate of Standards, Guides 
and Protocols of the Ministry of Public Health and Social Welfare  
Tel.: 809-541-3121 Ext. 4402/4 401 and 809 -854-9894 
Email: anel.payero@ministeriodesalud.gob.do  / normas@ministeriodesalud.gob.do  
3. Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [X], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], 
other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : Cosmetics . 
Toiletries (ICS code : 71.100.70)  
5. Title, number of pages and language(s) of the notified document : REGLAMENTO 
TÉCNICO QUE REGULA LA COMERCIALIZACIÓN DE PRODUCTOS COSMÉTICOS, DE 
HIGIENE PERSONAL Y DEL HOGAR  (Technical regulation governing the marketing of 
cosmetic, personal care and household care products) ; (62 pages, in Spanish)  
6. Description of content : 1. Introduction  
2. Ministerial Resolution  
3. Purpose  
4. Scope of application  
5. Legal framework  
6. General provisions  
7. Accepted references for the manufacture of cosmetics, personal care and household 
care products  
8. Mandatory Sanitary Notification for Cosmetics, Personal Care and Household Care 
Products  
9. Obligations of the applicant with respect to the Mandatory Sanitary Notification for 
cosmetics, personal care and household care products  G/TBT/N/DOM/233  
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  10. Documentation and requirements for the mandatory sanitary notification for cosmetic, 
personal care and household care products  
11. Quality documentation of cosmetics, personal care and household care  products  
12. Labelling and/or packaging  
13. Labelling of products marketed through co -marketing campaigns  
14. Other labelling regulations  
15. Mandatory Sanitary Notification amendments  
16. Documentation and requirements for updating packaging, labels and inserts  
17. Documentation and requirements for primary packaging changes  
18. Documentation and requirements for changing business name  
19. Documentation and requirements for ingredient changes  
20. Documentation and requirements for amending the name of the  applicant  
21. Documentation and requirements for change of co -distributor  
22. Documentation and requirements for change of packer  
23. Documentation and requirements for change of product specifications  
24. Documentation and requirements for change to shelf life  
25. Documentation and requirements for amending the name of the representative  
26. Documentation and requirements for change of name or trademark  
27. Documentation and requirements for the renewal of the mandatory sanitary 
notification for cosme tics, personal care and household care products  
28. Establishment that manufactures and distributes cosmetics, personal care and 
household care products  
29. Registration certificate for establishments that manufacture and distribute cosmetics, 
personal car e and household care products  
30. Good practices for the manufacture of cosmetics, personal care and household care 
products  
31. Good manufacturing practices and good storage practices  
32. Certificate of good manufacturing practices and Certificate of good  storage practices  
33. Export of cosmetic, personal care and household care products  
34. Documentation and requirements for imports of cosmetic, personal care and 
household care products  
35. Import documentation and requirements for cosmetic, personal care and household 
care products  
36. Documentation and requirements for the import of samples of no commercial value  
37. Sanitary control and surveillance of cosmetic, personal care and household care 
products  
38. Sanctions and their enforcement p rocedures  
39. Suspension and cancellation of the mandatory sanitary notification for cosmetics, 
personal care and household care products  
40. Definitive cancellation of the mandatory sanitary notification, in the event that at least 
one of the following ir regularities occurs  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Consumer information ; Labelling ; Prevention of misleading practices ; G/TBT/N/DOM/233  
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  Consumer protection ; Protection of human health and safety ; Protection of the 
environment ; Quality requirements.  
8. Relevant documents:  
NORDOM 778  Cosméticos . Buenas prácticas de manufactura (BPM)  
ISO 22716  Cosmetics -Good Manufacturing Practices (GMP) - Guidelines on Good 
Manufacturing Practices  
RTCA 71 .01.35:06 Productos Cosmético s. Registro e Inscripción Sanitaria de Productos 
Cosméticos.  
RTCA 71 .03.36:07 Productos Cosméticos . Etiquetado de Productos Cosméticos.  
RTCA 71 .03.45:07 Productos Cosméticos . Verificación de la Calidad.  
RTCA 71 .03.49:08 Productos Cosméticos . Buenas Práctic as de Manufactura para los 
Laboratorios Fabricantes de Productos Cosméticos.  
9. Proposed date of adoption : This technical regulation is mandated by Decree No. 125-
22, Article 4 of which states that the Ministry of Public Health and Social Welfare ( MISPAS) 
shall, by means of a resolution, issue the technical regulation within a period of not more 
than four months.  
Proposed date of entry into force : Article 7 of the aforementioned Decree proposes a 
transitional period and gives the Directorate -General  of Medicines, Food and Healthcare 
Products (DIGEMAPS) 90 day to process the applications currently filed and pending 
sanitary registration for cosmetics, and personal care and household care products ; 6 
months after its adoption  
10. Final date for commen ts: 60 days from notification  
11. Texts available from : National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Servicio Nacional de Información sobre OTC  (National TBT enquiry point)  
Viceministerio de Comercio Exterior  (VICOMEX)  
Ministerio de Industria, Comercio y Mypimes  (MICM)  
Avenida 27 de Febrero No. 306 
Torre MICM  
Bella Vista  
Tel.: (+1 809) -685-5171 
Email: rdotc@micm.gob.do  
Website: https://micm.gob.do  
https://members.wto.org/ crnattachments/2023/TBT/DOM/23_0985_00_s.pdf  
https://members.wto.org/crnattachments/2023/TBT/DOM/23_0985_01_s.pdf