Exceedence of quota

In recent months, the FAMHP has been repeatedly contacted regarding exceedances of donor quotas. These exceedances have been observed in some fertility centres as well as at national level. They concern both centre-specific donors and foreign donors, with or without the issuance of a Rapid Alert.

In line with the recovery plan, the FAMHP therefore aims to provide clear, transparent and contextualised explanations to facilitate the interpretation of the information published in the tables below.
It is important to emphasise that the presented data are based on information currently available, provided by fertility centres as part of inspections and biovigilance notifications. These figures are subject to change depending on new information and will be updated monthly.

In this context, the FAMHP cannot guarantee the completeness of the published data.

In addition, the FAMHP is actively continuing to update Fertidata, with the aim of obtaining a more exhaustive and accurate view of potential quota exceedances.
For any questions regarding the interpretation of general information, a Q&A is available on our website.

_____________________________________________

Rapid Alert
Global view of quota exceedance


Legend donor ID

_____________________________________________

Rapid Alert

The table below lists the 31 European Rapid Alerts where the Belgian legal limit of six women having had at least one child per donor, was exceeded (starting from 2022). Number of women who have had at least one child (treatment in Belgium).

The data presented in this table depend on the information provided by the fertility centres. This overview may be updated as further information becomes available. The published data therefore reflect the current situation and may be incomplete.

The number of pregnancies in this table does not necessarily correspond to confirmed pregnancies or births. There may be a discrepancy between the number of pregnancies, the number of children and the data available at the time of reporting (e.g. terminated pregnancies, ongoing pregnancies, new pregnancies).
It is important to note that blocking a donor does not prevent their gametes from being used for intended parents with the aim of conceiving a sibling of an already born child, based on a donation from that same donor. Although the number of families will no longer increase, the number of children within the same family may still change.

A Rapid Alert is a notification issued by a competent authority of a Member State of the European Union to inform other concerned Member States in the event of a health risk related to the use of tissues and cells. When a sperm donor is the subject of a Rapid Alert, this donor is permanently blocked and their sperm may no longer be used for the treatment of a new woman.

Donor X

Donor sperm bank

Other countries using the donor

Number of women who have had at least one child in Belgium

Number of children

Number of Belgian fertility centres that received the donor’s sperm

Year the Rapid Alert was issued

Confirmed risk associated with use of the donor’s sperm

Donor 1

ESB

AT, DE, FI, FR, IE, IS, MT, NL, NO, PT, SE, XI

7

9

6

2022

First blockage:

Donor is a carrier of classic galactosemia.
His gametes are permanently blocked 23MAY2022.

 

Second blockage:

The donor is carrier of Shwachman-Diamond syndrome. 
His gametes were already permanently blocked in May 2022 due to his carrier status 
of classic galactosemia.

Donor 2

ESB

BG, ES, GR, HU, IT, LV, PL

20

20

13

2022

A pathogenic variant in the PHA gene has been identified in donor and he is a carrier 
of PKU why his gametes are permanently blocked 11JUL2022.

Donor 3

ESB

AT, CY, DE, FI, HU, IE, IS, MT, NL,

NO, PT, SE, XI

11

11

5

2022

Donor is a carrier of autosomal recessive inherited mild-to-moderate sensorineural 
hearing loss due to a STRC deletion and according to the current interpretation of 
the Danish legislation his gametes are permanently blocked 02SEP2022.

Donor 4

ESB

AT CY DE FI IE IS NL NO PT SE XI

14

14

4

2022

The donor is a carrier of congenital disorder of glycosylation type Ia.
His gametes are permanently blocked 15DEC2022.

Donor 5

ESB

HU PL

17

22

13

2023

Hip dysplasia in a donor confers an increased risk to his offspring. 
His gametes are permanently blocked 18JAN2023.

Donor 6

ESB

GR IE PL

9

11

8

2023

Donor is a carrier of c.10955delC(p.Pro3652Glnfs*2) in the PKHD1 gene. 
His gametes are to be permanently blocked 20MAR2023.

Donor 7

ESB

PL

11

11

9

2023

A deletion of exon 11-14 in the GLI2 gene in a donor child does confer an increased risk 
to donor’s offspring. His gametes are permanently blocked 24MAR2023.

Donor 8

ESB

ES GR HU

8

10

8

2023

Donor is compound heterozygous for hemochromatosis. 
His gametes are therefore permanently blocked 15JUN2023.

Donor 9

ESB

ES GR IE IS IT LV PL

8

8

7

2023

A duplication of 22q11 in the donor might confer an increased risk to his offspring. 
His gametes are permanently blocked 04JUL2023.

Donor 10

ESB

AT DE FI FR GB IE IS NL NO PT SE

12

16

5

2023

The genetic examination of the donor shows that he has a deletion in exon 16-29 of 
the STRC gene. Hearing impairment in a donor child may confer an increased risk 
to donor’s offspring. Donor’s gametes are blocked 05JUL2023.

Donor 11

ESB

AT CY DE EE FI FR GB IE IS NL NO

PT SE

10

11

4

2023

Donor investigation shows donor to be a carrier of 57kb deletion in the CTNS-gene. A 57 kb deletion in CTNS-gene in a donor child does confer an increased risk to donor’s offspring. Donor’s gametes are to be permanently blocked 08AUG2023.

Donor 12

ESB

BG CY DE ES GR HU IE IS NL PL

38

53

14

2023

TP53 variant in a donor does confer an increased risk to donor’s offspring. 
His gametes are permanently blocked 30OCT2023.

Donor 13

ESB

ES IT LV

12

15

8

2023

The donor has been under investigation and the results have shown that he is a carrier 
of neonatal Zellweger syndrome, since he is heterozygous for the mutation in the PEX6 
gene. Zellweger syndrome in a donor child does confer an increased risk to donor’s 
offspring. His gametes are permanently blocked 07DEC2023.

Donor 14

ESB

AT DE FI IE IS LU MT NL NO PT SE XI

11

12

6

2023

Genetic testing showed that Donor is carrier of one of the two RAG2 variants. 
RAG2 deficiency results in the severe phenotype Severe combined immune deficiency 
SCID. Due to the fact that donor is known carrier of a recessive gene variant he is permanently blocked 08NOV2023.

Donor 15

ESB

AT DE GB IS NL NO PT SE

7

8

4

2024

Isovaleric acidemia in a donor child, and subsequent genetic analysis showing that 
donor is heterozygous carrier of a pathogenic variant in the IVD gene; 
c.158G>A,p.Arg53His, does confer an increased risk to donor’s offspring. 
His gametes are therefore permanently blocked 20DEC2023.

Donor 16

ESB

HU

10

10

10

2024

The donors Family history reveals that the PD has an unspecified hernia, 
his identical twin brother was born with coarctation of his aorta and his paternal aunt 
was born with only one kidney. Hydronephrosis in a donor child does confer an 
increased risk to donor’s offspring. 
His gametes are therefore permanently blocked 31Jan2024.

Donor 17

ESB

BG EE ES GR HU IE IT LV PL

18

23

9

2024

MSH2 variant in a donor does confer an increased risk to donor’s offspring. 
His gametes are to be permanently blocked.

Donor 18

ESB

ES GR

14

16

8

2024

The pathogenic variant ing the GAA gene was identified in the donor. 
Biallellic pathogenic variants in the GAA gene cause Pompes disease. 
A pathogenic variant in the GAA gene does confer an increased risk to a donor child. 
His gametes are to be permanently blocked.

Donor 19

ESB

ES IT MT PL

8

12

9

2024

Pathogenic MYBPC3 variant in a fetus and found in the donor confers an increased risk 
to donor’s offspring. 
His gametes are permanently blocked 07NOV2024.

Donor 20

ESB

BG CY ES GR HU IS IT LV PL RO

21

24

10

2024

Cardiomyopathy in a donor child and subsequent diagnosis of heterozygosity of a 
pathogenic variant in APLK3 gene in the donor confers an increased risk to donor’s 
offspring. The donor is blocked and his gametes can no longer be used. 
The case is closed and reported to the Danish Patient Safety Authorities. 19NOV2024.

Donor 21

ESB

BG EE FR GR HU IS LT LV PL RO

17

20

10

2025

Investigation of donor shows a 109kb deletion involving the NRXN1 gene.
Donor will be permanently blocked 21JAN2025.

Donor 22

Cryos

AT BG CY DE ES FR GB GR HU

IE IT LU LV NL PL RO SE

11

12

4*

2025

Donor has been tested and carries a variant in USH2A. The risk of an affected child is 
lower than 1%. Donor gametes were blocked for new customers (<1% recurrence risk) 
02NOV2022 but can be used for siblings.
Reported to the Danish Patient Safety Authority 25FEB2025.

Donor 23

ESB

BG CY EE ES GR HU IT LV PL

27

34

14

2025

The donor has been investigated and has an extraordinary genetic constellation since 
he has 3 copies of the FBN1 gene: 2 normal FBN1 genes and a copy of FBN1 with 
deletion of exon 1-. Donor gametes are blocked 30APR 2025. We recommend that 
donor conceived children of donor are referred for paediatric evaluation to assess the 
relevance of genetic counselling and examination.

Donor 24

ESB

AT CY DE FR GB GR IE IS NL PT

SE

10

10

5

2025

We can conclude that the donor has a genotype with a deletion of SMN1 on one 
chromosome and two copies of SMN1 on the other chromosome. The donor will be
permanently blocked 20JAN2025.

Donor 25

ESB

BG CY CZ EE ES GR HU IE IS IT LT LU PL RO

19

27

12

2025/2026

First blockade : The donor is found to be a healthy carrier of a pathogenic variant in the CYP21A2 gene. Non-Classical congenital adrenal hyperplasia (CAH) due to compound heterozygous mutations in the CYP21A2 gene in a donor child confers an increased risk to donor's offspring. His gametes are permanently blocked.
The case is reported to the Danish Patient Safety Authorities. 07JUL2025.

Second blockade : Gametes of the donor were previously pemanently blocked because
he is a carrier of a pathogenic variant in the CYP21A2 gene. A new permanent block
notification will be issued because the donor is a carrier of a pathogenic variant in the NPC1 gene. 

Donor 26

ESB

FR GR HU IS LV PL

9

9

8

2025

Deletion of the CYP21A2 gene in a donor does confer an increased risk to donor’s 
offspring. His gametes are to be permanently blocked. The case is closed and reported 
to the Danish Patient Safety Authorities. 19AUG2025.

Donor 27

ESB

ES IT NL PL

12

15

10*

2025

A pathogenic (class V) genetic variant was observed in the Thyroglobulin (TG) gene. 
Congenital hypothyroidism in a donor child does confer an increased risk to donor’s
offspring. His gametes are to be permanently blocked. The case is closed and is to be 
reported to the Danish Patient Safety Authorities. 13OCT2025.

Donor 28

ESB

BG CY DE ES FR GR HU IE IS IT LT LU LV PL RO SE XI

22

29

10

2025

The donor is a carrier of Metachromatic leukodystrophy (MLD), since a pathogenic 
genetic variant in the Arylsulfatase A (ARSA) gene is identified in a heterozygous state.
A pathogenic genetic variant :NM_000487.6:c.917C>T, identified in the donor does confer an increased reproductive risk. His gametes are to be permanently blocked. 
20OCT2025.

Donor 29

ESB

BG CY EE ES FR GR HU IE IS IT LV PL 

14 

22

10

2025

The donor has been under investigation and the results have shown that he is a
healthy carrier of Spinal Muscular Atrophy, since MLPA analysis shows a deletion 
of one of the SMN1 genes. 

Donor 30

ESB

BG CY EE FR GR HU IS LV PL RO

10

11

10

2025

The CHEK2 variant c1100delC found in the donor confers an increased risk to donor's
offspring. The donor will be permanently blocked and the case reported to Danish
health authorities. 27NOV2025

Donor 31

ESB

CY DE ES FI FR GR IE IT LU MT NL PL PT

28

31

10

2026

A donor child has been diagnosed with Carnitine palmitoyltransferase type 2 deficiency,
with the same pathogenic variant of her CPT2 gene, meaning homozygous.
It is inherited in a recessive manner, which means that both copies of the CPT2 gene
must be affected to develop the disease. Both genetic parents are likely to be carriers
of the condition, meaning that only one copy of their CPT2 gene has a pathogeninc variant. 
Donor gametes are blocked 07 april 2026.

* private recipient(s)

2. Global view of quota exceendance

The table below shows all the quota exceedances of which the FAMHP is currently aware. It also includes the Rapid Alerts mentioned above.
These situations have been brought to the agency's attention through various channels:

  • via biovigilance notifications that did not result in a Rapid Alert,
  • during inspections
  • or following voluntary reports from fertility centres.

The table sets out all exceedances recorded per donor, regardless of the number of centres involved.

When an exceedance relating to a donor has been identified within a single centre — for example when that centre has used the same donor for more than six families — this information is explicitly stated in the last column (‘quota exceedance within a centre’).
An empty column means that the exceedance is spread across several centres, with no individual centre having exceeded the limit of six families.

This overview contributes to increased transparency, consistent monitoring of identified situations, and an overall assessment of compliance with current quotas.

# Rapid alert/
Other notifications
Internal
Donor ID 
Origin Nbr
families 
Nbr
children 
Nbr
institution 
Notification
year
Quota exceedance
within a centre
1 Rapid Alert  1 ESB 7 9 6 2022  
2 Rapid Alert  2 ESB 20 20 13 2022  
3 Rapid Alert  3 ESB 11 11 5 2022  
4 Rapid Alert  4 ESB 14 14 4 2022  
5 Rapid Alert  5 ESB 17 22 13 2023  
6 Rapid Alert  6 ESB 9 11 8 2023  
7 Rapid Alert  7 ESB 11 11 9 2023  
8 Rapid Alert  8 ESB 8 10 8 2023  
9 Rapid Alert  9 ESB 8 8 7 2023  
10 Rapid Alert  10 ESB 12 16 5 2023  
11 Rapid Alert  11 ESB 10 11 4 2023  
12 Rapid Alert  12 ESB 38 53 14 2023 Centre 11
13 Rapid Alert  13 ESB 12 15 8 2023  
14 Rapid Alert  14 ESB 11 12 6 2023  
15 Rapid Alert  15 ESB 7 8 4 2024  
16 Rapid Alert  16 ESB 10 10 10 2024  
17 Rapid Alert  17 ESB 18 23 9 2024  
18 Rapid Alert  18 ESB 14 16 8 2024  
19 Rapid Alert  19 ESB 8 12 9 2024  
20 Rapid Alert  20 ESB 21 24 10 2024  
21 Rapid Alert  21 ESB 17 20 10 2025  
22 Rapid Alert  22 Cryos 11 12 4* 2025  
23 Rapid Alert  23 ESB 27 34 14 2025  
24 Rapid Alert  24 ESB 10 10 5 2025  
25 Rapid Alert  25 ESB 19 27 12 2025/2026  
26 Rapid Alert  26 ESB 9 9 8* 2025  
27 Rapid Alert  27 ESB 12 15 10* 2025  
28 Rapid Alert  28 ESB 22 29 10 2025  
29 Rapid Alert  29 ESB 14 22 10 2025  
30 Rapid Alert  30 ESB 10 11 10 2025  
31 Rapid Alert  31 Cryos 28 31 10 2026 Centre 11/Centre 25
32 Rapid Alert  R1 ESB 16 20   2012  
33 Rapid Alert  R2 Cryos > 6     2016 Centre 9
34 Rapid Alert  R3 Cryos > 6     2018 Centre 25
35 Rapid Alert  R4 Cryos > 6     2019 Centre 25
36 Rapid Alert  R5 Cryos > 6     2019 Centre 25
37 Rapid Alert  R6 ESB > 6     2019 Centre 7/Centre 23/ Centre 25
38 Rapid Alert  R7 Cryos > 6     2019 Centre 25/Centre 9
39 Rapid Alert  R8 Cryos > 6     2019 Centre 25
40 Rapid Alert  R9 Cryos > 6     2019 Centre 25
41 Rapid Alert  R10 ESB > 6     2020  
42 Rapid Alert  R11 ESB 7     2020  
43 Rapid Alert  R12 ESB 11     2020  
44 Rapid Alert  R13 ESB 8     2020  
45 Rapid Alert  R14 Cryos 17     2020 Centre 25/
Centre 9
46 Rapid Alert  R15 Cryos 8     2020  
47 Rapid Alert  R16 Cryos 8     2020  
48 Rapid Alert  R17 ESB > 6     2020  
49 Rapid Alert  R18 ESB 9     2020  
50 Rapid Alert  R19 ESB 33     2021  
51 Rapid Alert  R20 ESB 15     2021  
52 Rapid Alert  R21 ESB 11     2021  
53 Rapid Alert  R22 ESB 10     2021  
54 Rapid Alert  R23 ESB 7     2021  
55 Internal donnor  B1 Own bank 16     2019 Centre 25
56 Internal donnor  B2 Own bank 8     2021 Centre 25
57 Internal donnor  B3 Own bank 7     2022 Centre 25
58 Internal donnor  B4 Own bank 9     2022 Centre 25
59 Internal donnor  B5 Own bank 10     2023 Centre 25
60 Internal donnor  B6 Own bank 7     2023 Centre 25
61 Internal donnor  B7 Own bank 8     2024 Centre 25
62 Internal donnor  B8 Own bank 7     2025 Centre 30
63 Internal donnor  B9 Own bank 13     2025 Centre 25
64 Internal donnor  B10 Own bank 8     2025 Centre 9
65 Internal donnor  B11 Own bank 25     2026 Centre 25
66 Internal donnor  B12 Own bank 7     2026 Centre 10
67 European donnor without RA  E1 ESB > 6     2025  
68 European donnor without RA  E2 ESB > 6     2025  
69 European donnor without RA  E3 ESB > 6     2025  
70 European donnor without RA  E4 ESB > 6     2025  
71 European donnor without RA  E5 ESB > 6     2025  
72 European donnor without RA  E6 ESB > 6     2025  
73 European donnor without RA  E7 ESB > 6     2025  
74 European donnor without RA  E8 ESB > 6     2025  
75 European donnor without RA  E9 ESB > 6     2025  
76 European donnor without RA  E10 ESB > 6     2025  
77 European donnor without RA  E11 ESB > 6     2025  
78 European donnor without RA  E12 ESB > 6     2025  
79 European donnor without RA  E13 ESB > 6     2025  
80 European donnor without RA  E14 ESB > 6     2025  
81 European donnor without RA  E15 ESB > 6     2025  
82 European donnor without RA  E16 ESB > 6     2025  
83 European donnor without RA  E17 Cryos > 6     2026  
84 European donnor without RA  E18 ESB > 6     2026  
85 European donnor without RA  E19 ESB > 6     2026  
86 European donnor without RA  E20 ESB > 6     2026  
87 European donnor without RA  E21 ESB > 6     2026  
88 European donnor without RA  E22 Cryos 11     2025 Centre 9
89 European donnor without RA  E23 Cryos 10     2025 Centre 9
90 European donnor without RA  E24 Cryos 10     2025 Centre 9
91 European donnor without RA  E25 Cryos 9     2025 Centre 9
92 European donnor without RA  E26 ESB 7     2025 Centre 11
93 European donnor without RA  E27 ESB 8     2025 Centre 11
94 European donnor without RA  E28 Cryos 7     2025 Centre 11

* private recipient(s)


Legend donor ID

  • A. Foreign donor with Rapid Alert (issued between 2022 and today)
    Donor identified by a number (e.g. donor 5).
  • B. Foreign donor with Rapid Alert (issued prior to 2022)
    Donor identified by the letter ‘R’ followed by a number (e.g. donor R5).
  • C. Foreign donor without Rapid Alert
    Donor identified by the letter ‘E’ followed by a number (e.g. donor E5).
    ⚠️ If a Rapid Alert is issued at a later stage, the donor is removed from this category and reclassified into category A.
  • D. Centre-specific donor
    Donor identified by the letter ‘B’ followed by a number (e.g. donor B5).
Last updated on