The objective of this epidemiological study was to assess the incidence at birth of orofacial clefts in Croatia.The aim of the present study was to analyse the character and incidence of orofacial clefts in Croatia and to compare the data with reports from other countries.All the material for the epidemiological study was retrieved from the documented files from all the neonatal units and hospitals in Croatia providing surgical treatment.A total of 525,298 livebirths were documented during 11 years (1988-1998); 903 among them with orofacial clefts, 24 (2.7%) of them twins. Sixty (6.6%) infants died between birth and the age of 6 months. The incidence of orofacial clefts during the study period was 1.71 per thousand. When eliminating syndromic clefts, the incidence of non-syndromic clefts was 1.56 per thousand. Analysis of cleft lip with or without cleft palate (CL+/-P) and isolated cleft palate only (CP) revealed their incidence to be 1.05 and 0.66 per 1000, respectively. Of all types of clefting, CL and CLA was found in 17.2%, CL+/-P in 43.9%, CP in 38.2% and atypical facial clefts (AFC) in 0.8% of children. Left-sided clefts were most common (51%), followed by bilateral (30.5%) and right-sided (18.5%) clefts. The male to female ratio was 1.3. CL+/-P predominated in male and CP in female children. In 220 cases (24.4%) orofacial clefts were either associated with other anomalies or the clefts occurred as one feature of a syndrome.Data obtained from different sources yielded a cleft incidence of 1.71 per 1000 in Croatia. There were no differences in the incidences of orofacial clefts in comparison with similar data from other European countries.