Pöördumine

EN 0 EN

RULES OF PROCEDURE FOR THE REGULATORY COMMITTEE ON

STANDARDS OF QUALITY AND SAFETY FOR SUBSTANCES OF HUMAN

ORIGIN

THE REGULATORY COMMITTEE ON STANDARDS OF QUALITY AND SAFETY FOR

SUBSTANCES OF HUMAN ORIGIN,

Having regard to Regulation (EU) 2024/1938 of the European Parliament and of the Council of

13 June 2024 on standards of quality and safety for substances of human origin intended for

human application and repealing Directives 2002/98/EC and 2004/23/EC1 and in particular

Article 79 thereof,

Having regard to Regulation (EU) No 182/2011 of the European Parliament and of the Council

of 16 February 2011 laying down the rules and general principles concerning mechanisms for

control by Member States of the Commission's exercise of implementing powers2, and in

particular Article 9(1) thereof,

Having regard to the standard rules of procedure published by the Commission3,

HAS ADOPTED THE FOLLOWING RULES OF PROCEDURE:

Article 1

Convening a meeting

1. A meeting of the committee shall be convened by the chair (a representative of the

Commission, as provided in Article 3(2) of Regulation (EU) No 182/2011), either on

their own initiative, or at the request of a simple majority of members of the committee.

2. In the case referred to in the second subparagraph of Article 3(5) of Regulation (EU)

No 182/2011, where the written procedure is terminated without result, the chair shall

convene a committee meeting within a reasonable time.

3. Joint meetings of the committee with other committees may be convened to discuss

issues coming within their respective areas of responsibility.

Article 2

Agenda

1. The chair shall draw up the agenda and submit it to the committee.

2. The agenda shall make a distinction between:

(a) draft implementing acts to be adopted by the Commission on which the committee

is asked to give an opinion, in accordance with the examination procedure

provided for in Article 79(2) of Regulation (EU) 2024/1938;

(b) other issues put to the committee for information or a simple exchange of views,

either on the chair's initiative, or at the written request of a member of the

committee.

1 OJ L, 2024/1938, 17.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1938/oj 2 OJ L 55, 28.2.2011, p 13. 3 OJ C 206, 12.7.2011, p. 11.

EN 1 EN

Article 3

Documentation to be submitted to members of the committee

1. For the purpose of the second subparagraph of Article 3(3) of Regulation (EU) No

182/2011, the chair shall submit the invitation, the draft agenda and the draft

implementing act on which the committee is asked to give an opinion to the members

of the committee well in advance of the meeting, taking into account the urgency and

the complexity of the matter, and no later than 14 calendar days before the date of the

meeting. Other documents related to the meeting, in particular documents

accompanying the draft implementing act, shall, as far as possible, be submitted within

the same time-limit.

All documents shall be submitted in accordance with Article 12(2).

2. In duly justified cases, the chair may, on their own initiative or at the request of a

member of the committee, shorten the time limit for submission of documents referred

to in paragraph 1. Except in cases of extreme urgency, the time limit shall not be shorter

than five calendar days.

Article 4

Opinion of the committee

1. The committee shall deliver its opinion on a draft implementing act within the time limit

laid down by the chair in accordance with the second subparagraph of Article 3(3) of

Regulation (EU) No 182/2011.

2. Where the committee's opinion is required under the examination procedure, the

outcome of the vote shall be decided by a qualified majority, in accordance with Article

5(1) of Regulation (EU) No 182/2011.

3. Unless a member of the committee objects, the chair may, without proceeding to a

formal vote, establish that the committee has delivered a positive opinion, by consensus,

on the draft implementing act.

4. The chair, in consultation with the members of the committee, may, on their own

initiative or at the request of a member of the committee, postpone a vote until the end

of the meeting or to a later meeting.

5. In accordance with the second subparagraph of Article 3(4) of Regulation (EU) No

182/2011, the chair shall endeavour to find solutions which command the widest

possible support within the committee. Before the vote, the chair shall inform the

committee of the manner in which the discussions and suggestions for amendments have

been taken into account, in particular as regards those suggestions which have been

largely supported within the committee.

Article 5

Representation

1. Each Member State shall be considered to be one member of the committee. Each

member of the committee shall decide on the composition of its delegation and inform

the chair. With the chair's permission, the delegations may be accompanied by experts

who are not part of the delegation.

2. Within a reasonable time and no later than five calendar days before the date of a

committee meeting, the following information shall be communicated to the chair:

EN 2 EN

a) The composition of each delegation, except where such composition is already

known to the chair;

b) names and functions of any experts accompanying the delegations and the reasons

for which their presence is required.

If the chair does not object to the participation of an expert in advance of the committee

meeting, the permission referred to in paragraph 1 is considered to be granted.

3. The reimbursement of travel expenses by the Commission shall be paid in accordance

with the applicable rules, subject to budgetary funds provided for this purpose.

4. A Member State delegation may represent a maximum of one other Member State. The

Member State that is being represented shall inform the chair of this before the meeting,

or, at the latest, before the vote.

Article 6

Working groups

1. The committee may create working groups to examine particular issues. The working

groups shall be chaired by a representative of the Commission.

2. The working groups shall report back to the committee under the responsibility of their

chair.

Article 7

Third parties and experts

1. The representatives of third countries or organisations who are entitled by a binding

legal act to be present in the committee meeting shall be invited to attend the meetings

of the committee in accordance with the respective legal act.

2. Representatives of acceding countries shall be invited to attend the meetings of the

committee as from the date of signature of the Treaty of Accession.

3. The chair may decide to invite representatives of other third parties or other experts to

talk on particular matters, on their own initiative or at the request of a member of the

committee. However, a simple majority of the component members of the committee

may oppose their participation in the meeting.

4. Representatives of third parties and experts referred to in paragraphs 1, 2 and 3 shall not

be present at and shall not participate in voting of the committee.

Article 8

Written procedure

1. The chair may obtain the committee's opinion by written procedure in accordance with

Article 3(5) of Regulation (EU) No 182/2011. In particular, the chair may use the written

procedure to obtain the committee's opinion in cases where the draft implementing act

has already been discussed during a committee meeting.

2. The chair shall inform the members of the committee of the outcome of the written

procedure without delay, and no later than 14 calendar days after the expiry of the time

limit.

EN 3 EN

Article 9

Secretarial support

The Commission shall provide secretarial support for the committee and, if necessary, the

working groups created pursuant to Article 6(1).

Article 10

Minutes and summary record of meetings

1. For the purpose of Article 3(6) of Regulation (EU) No 182/2011, the minutes of each

meeting shall be drawn up under the responsibility of the chair. Committee members

shall have the right to ask for their position to be recorded in the minutes. The chair shall

send the minutes to the committee members without delay and no later than one month

after the meeting.

The members of the committee shall send any comments they may have on the draft

minutes to the chair in writing. If there is any disagreement, the matter shall be discussed

by the committee. If the disagreement persists, the relevant comments shall be annexed

to the final minutes.

2. For the purpose of Article 10 of Regulation (EU) No 182/2011, the chair shall be

responsible for drawing up a summary record briefly describing each item on the agenda

and the results of the vote on any draft implementing act submitted to the committee.

The summary record shall not mention the individual position of the members in the

committee's discussions.

Article 11

Attendance list and conflicts of interest

1. At each meeting, the chair shall draw up an attendance list specifying the authorities

and organisations to which the persons designated by the Member States to represent

them belong.

2. At the beginning of each meeting, any person designated by the Member States, as well

as experts who have been authorised by the chair to participate in the meeting in

accordance with Article 5(1) and Article 7(3), and representatives of third parties who

have been invited to attend the meeting in accordance with Article 7, shall inform the

chair of any conflict of interest4 with regard to a particular item on the agenda.

In the event of such a conflict of interest, the person concerned shall, at the request of

the chair, withdraw from the meeting whilst the relevant items of the agenda are being

dealt with.

Article 12

Correspondence

1. Correspondence relating to the committee shall be submitted to the Commission, for the

attention of the chair of the committee.

4 As an example, Article 61(3) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of

the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending

Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU)

No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No

541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30/07/2018,, p. 1)

contains a specific definition of a conflict of interest.

EN 4 EN

2. Correspondence for members of the committee shall be submitted to the Permanent

Representations of the Member States, preferably by electronic means. Where a

Permanent Representation indicates to the Commission a specific central electronic

address for correspondence related to work of the committees, that address shall be used

for correspondence. In addition, correspondence may be submitted directly to the

persons designated by the Member States to represent them in the committee.

Article 13

Access to documents and confidentiality

1. Requests for access to committee documents shall be handled in accordance with

Regulation (EC) No 1049/2001 of the European Parliament and of the Council5. It is for

the Commission to take a decision on requests for access to those documents pursuant

to its Rules of Procedure as amended by Decision 2001/937/EC, ECSC, Euratom6. If

the request is addressed to a Member State that Member State shall apply Article 5 of

Regulation (EC) No 1049/2001.

2. The committee's discussions shall be confidential.

3. Documents submitted to members of the committee, experts and representatives of third

parties shall be confidential7, unless access is granted to those documents pursuant to

paragraph 1 or they are otherwise made public by the Commission.

4. The members of the committee, as well as experts and representatives of third parties,

shall be required to respect the confidentiality obligations set out in this Article. The

chair shall ensure that experts and representatives of third parties are made aware of the

confidentiality requirements imposed upon them.

Article 14

Protection of personal data

The processing of personal data by the committee and its working groups shall be in conformity

with Regulation (EU) 2018/1725 of the European Parliament and of the Council8, under the

responsibility of the chair acting as a controller, within the meaning of point (8) of Article 3 of

that Regulation.

5 OJ L 145, 31.5.2001 p. 43. 6 OJ L 345, 29.12.2001, p. 94. 7 In accordance with Article 339 TFEU, "[t]he members of the institutions of the Union, the members of

committees, and the officials and other servants of the Union shall be required, even after their duties

have ceased, not to disclose information of the kind covered by the obligation of professional secrecy, in

particular information about undertakings, their business relations or their cost components". 8 OJ L 295, 21.11.2018, p. 39–98.

EN 0 EN

RULES OF PROCEDURE FOR THE REGULATORY COMMITTEE ON

STANDARDS OF QUALITY AND SAFETY FOR SUBSTANCES OF HUMAN

ORIGIN

THE REGULATORY COMMITTEE ON STANDARDS OF QUALITY AND SAFETY FOR

SUBSTANCES OF HUMAN ORIGIN,

Having regard to Regulation (EU) 2024/1938 of the European Parliament and of the Council of

13 June 2024 on standards of quality and safety for substances of human origin intended for

human application and repealing Directives 2002/98/EC and 2004/23/EC1 and in particular

Article 79 thereof,

Having regard to Regulation (EU) No 182/2011 of the European Parliament and of the Council

of 16 February 2011 laying down the rules and general principles concerning mechanisms for

control by Member States of the Commission's exercise of implementing powers2, and in

particular Article 9(1) thereof,

Having regard to the standard rules of procedure published by the Commission3,

HAS ADOPTED THE FOLLOWING RULES OF PROCEDURE:

Article 1

Convening a meeting

1. A meeting of the committee shall be convened by the chair (a representative of the

Commission, as provided in Article 3(2) of Regulation (EU) No 182/2011), either on

their own initiative, or at the request of a simple majority of members of the committee.

2. In the case referred to in the second subparagraph of Article 3(5) of Regulation (EU)

No 182/2011, where the written procedure is terminated without result, the chair shall

convene a committee meeting within a reasonable time.

3. Joint meetings of the committee with other committees may be convened to discuss

issues coming within their respective areas of responsibility.

Article 2

Agenda

1. The chair shall draw up the agenda and submit it to the committee.

2. The agenda shall make a distinction between:

(a) draft implementing acts to be adopted by the Commission on which the committee

is asked to give an opinion, in accordance with the examination procedure

provided for in Article 79(2) of Regulation (EU) 2024/1938;

(b) other issues put to the committee for information or a simple exchange of views,

either on the chair's initiative, or at the written request of a member of the

committee.

1 OJ L, 2024/1938, 17.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1938/oj 2 OJ L 55, 28.2.2011, p 13. 3 OJ C 206, 12.7.2011, p. 11.

EN 1 EN

Article 3

Documentation to be submitted to members of the committee

1. For the purpose of the second subparagraph of Article 3(3) of Regulation (EU) No

182/2011, the chair shall submit the invitation, the draft agenda and the draft

implementing act on which the committee is asked to give an opinion to the members

of the committee well in advance of the meeting, taking into account the urgency and

the complexity of the matter, and no later than 14 calendar days before the date of the

meeting. Other documents related to the meeting, in particular documents

accompanying the draft implementing act, shall, as far as possible, be submitted within

the same time-limit.

All documents shall be submitted in accordance with Article 12(2).

2. In duly justified cases, the chair may, on their own initiative or at the request of a

member of the committee, shorten the time limit for submission of documents referred

to in paragraph 1. Except in cases of extreme urgency, the time limit shall not be shorter

than five calendar days.

Article 4

Opinion of the committee

1. The committee shall deliver its opinion on a draft implementing act within the time limit

laid down by the chair in accordance with the second subparagraph of Article 3(3) of

Regulation (EU) No 182/2011.

2. Where the committee's opinion is required under the examination procedure, the

outcome of the vote shall be decided by a qualified majority, in accordance with Article

5(1) of Regulation (EU) No 182/2011.

3. Unless a member of the committee objects, the chair may, without proceeding to a

formal vote, establish that the committee has delivered a positive opinion, by consensus,

on the draft implementing act.

4. The chair, in consultation with the members of the committee, may, on their own

initiative or at the request of a member of the committee, postpone a vote until the end

of the meeting or to a later meeting.

5. In accordance with the second subparagraph of Article 3(4) of Regulation (EU) No

182/2011, the chair shall endeavour to find solutions which command the widest

possible support within the committee. Before the vote, the chair shall inform the

committee of the manner in which the discussions and suggestions for amendments have

been taken into account, in particular as regards those suggestions which have been

largely supported within the committee.

Article 5

Representation

1. Each Member State shall be considered to be one member of the committee. Each

member of the committee shall decide on the composition of its delegation and inform

the chair. With the chair's permission, the delegations may be accompanied by experts

who are not part of the delegation.

2. Within a reasonable time and no later than five calendar days before the date of a

committee meeting, the following information shall be communicated to the chair:

EN 2 EN

a) The composition of each delegation, except where such composition is already

known to the chair;

b) names and functions of any experts accompanying the delegations and the reasons

for which their presence is required.

If the chair does not object to the participation of an expert in advance of the committee

meeting, the permission referred to in paragraph 1 is considered to be granted.

3. The reimbursement of travel expenses by the Commission shall be paid in accordance

with the applicable rules, subject to budgetary funds provided for this purpose.

4. A Member State delegation may represent a maximum of one other Member State. The

Member State that is being represented shall inform the chair of this before the meeting,

or, at the latest, before the vote.

Article 6

Working groups

1. The committee may create working groups to examine particular issues. The working

groups shall be chaired by a representative of the Commission.

2. The working groups shall report back to the committee under the responsibility of their

chair.

Article 7

Third parties and experts

1. The representatives of third countries or organisations who are entitled by a binding

legal act to be present in the committee meeting shall be invited to attend the meetings

of the committee in accordance with the respective legal act.

2. Representatives of acceding countries shall be invited to attend the meetings of the

committee as from the date of signature of the Treaty of Accession.

3. The chair may decide to invite representatives of other third parties or other experts to

talk on particular matters, on their own initiative or at the request of a member of the

committee. However, a simple majority of the component members of the committee

may oppose their participation in the meeting.

4. Representatives of third parties and experts referred to in paragraphs 1, 2 and 3 shall not

be present at and shall not participate in voting of the committee.

Article 8

Written procedure

1. The chair may obtain the committee's opinion by written procedure in accordance with

Article 3(5) of Regulation (EU) No 182/2011. In particular, the chair may use the written

procedure to obtain the committee's opinion in cases where the draft implementing act

has already been discussed during a committee meeting.

2. The chair shall inform the members of the committee of the outcome of the written

procedure without delay, and no later than 14 calendar days after the expiry of the time

limit.

EN 3 EN

Article 9

Secretarial support

The Commission shall provide secretarial support for the committee and, if necessary, the

working groups created pursuant to Article 6(1).

Article 10

Minutes and summary record of meetings

1. For the purpose of Article 3(6) of Regulation (EU) No 182/2011, the minutes of each

meeting shall be drawn up under the responsibility of the chair. Committee members

shall have the right to ask for their position to be recorded in the minutes. The chair shall

send the minutes to the committee members without delay and no later than one month

after the meeting.

The members of the committee shall send any comments they may have on the draft

minutes to the chair in writing. If there is any disagreement, the matter shall be discussed

by the committee. If the disagreement persists, the relevant comments shall be annexed

to the final minutes.

2. For the purpose of Article 10 of Regulation (EU) No 182/2011, the chair shall be

responsible for drawing up a summary record briefly describing each item on the agenda

and the results of the vote on any draft implementing act submitted to the committee.

The summary record shall not mention the individual position of the members in the

committee's discussions.

Article 11

Attendance list and conflicts of interest

1. At each meeting, the chair shall draw up an attendance list specifying the authorities

and organisations to which the persons designated by the Member States to represent

them belong.

2. At the beginning of each meeting, any person designated by the Member States, as well

as experts who have been authorised by the chair to participate in the meeting in

accordance with Article 5(1) and Article 7(3), and representatives of third parties who

have been invited to attend the meeting in accordance with Article 7, shall inform the

chair of any conflict of interest4 with regard to a particular item on the agenda.

In the event of such a conflict of interest, the person concerned shall, at the request of

the chair, withdraw from the meeting whilst the relevant items of the agenda are being

dealt with.

Article 12

Correspondence

1. Correspondence relating to the committee shall be submitted to the Commission, for the

attention of the chair of the committee.

4 As an example, Article 61(3) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of

the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending

Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU)

No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No

541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30/07/2018,, p. 1)

contains a specific definition of a conflict of interest.

EN 4 EN

2. Correspondence for members of the committee shall be submitted to the Permanent

Representations of the Member States, preferably by electronic means. Where a

Permanent Representation indicates to the Commission a specific central electronic

address for correspondence related to work of the committees, that address shall be used

for correspondence. In addition, correspondence may be submitted directly to the

persons designated by the Member States to represent them in the committee.

Article 13

Access to documents and confidentiality

1. Requests for access to committee documents shall be handled in accordance with

Regulation (EC) No 1049/2001 of the European Parliament and of the Council5. It is for

the Commission to take a decision on requests for access to those documents pursuant

to its Rules of Procedure as amended by Decision 2001/937/EC, ECSC, Euratom6. If

the request is addressed to a Member State that Member State shall apply Article 5 of

Regulation (EC) No 1049/2001.

2. The committee's discussions shall be confidential.

3. Documents submitted to members of the committee, experts and representatives of third

parties shall be confidential7, unless access is granted to those documents pursuant to

paragraph 1 or they are otherwise made public by the Commission.

4. The members of the committee, as well as experts and representatives of third parties,

shall be required to respect the confidentiality obligations set out in this Article. The

chair shall ensure that experts and representatives of third parties are made aware of the

confidentiality requirements imposed upon them.

Article 14

Protection of personal data

The processing of personal data by the committee and its working groups shall be in conformity

with Regulation (EU) 2018/1725 of the European Parliament and of the Council8, under the

responsibility of the chair acting as a controller, within the meaning of point (8) of Article 3 of

that Regulation.

5 OJ L 145, 31.5.2001 p. 43. 6 OJ L 345, 29.12.2001, p. 94. 7 In accordance with Article 339 TFEU, "[t]he members of the institutions of the Union, the members of

committees, and the officials and other servants of the Union shall be required, even after their duties

have ceased, not to disclose information of the kind covered by the obligation of professional secrecy, in

particular information about undertakings, their business relations or their cost components". 8 OJ L 295, 21.11.2018, p. 39–98.

To all Deputy Permanent Representatives of the EU Member States

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

The Director-General

Brussels SANTE.D.2/KB/eb/(2025) 2846059

By e-mail only

Subject: Nomination of representatives to the Regulatory Committee on

standards of quality and safety for substances of human origin

Your Excellency,

Regulation (EU) 2024/1938 on standards of quality and safety for substances of human

origin (SoHO) intended for human application (1) stipulates that the Commission shall

adopt an implementing act on the EU SoHO platform, as referred to in Article 74 of the

Regulation, at the latest by 7 August 2025, and the implementing acts as referred to in

Articles 41, 42, 43 and 48 at the latest by the date of application of this Regulation.

The Regulation provides that the Commission shall be assisted by a Committee, within the

meaning and with the tasks as laid down in Regulation (EU) No 182/2011 (2).

The members of the Regulatory Committee on standards of quality and safety for

substances of human origin shall be composed of representatives of the Member States.

Each Member State shall appoint their own representatives. In accordance with Regulation

(EU) No 182/2011, the Commission shall chair and provide the Secretariat of the

Committee. In accordance with Article 5(1) of the Standard rules of procedure for

committees (3), each Member State shall decide on the composition of its delegation and

inform the chair. With the chair's permission, the delegations may be accompanied by no

more than two experts who are not part of the delegation.

In view of the aforesaid, you are kindly invited to designate your representatives to the

Regulatory Committee on standards of quality and safety for substances of human origin.

(1) Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards

of quality and safety for substances of human origin intended for human application and repealing

Directives 2002/98/EC and 2004/23/EC. OJ L, 2024/1938, 17.7.2024, ELI:

http://data.europa.eu/eli/reg/2024/1938/oj

(2) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying

down the rules and general principles concerning mechanisms for control by Member States of the

Commission’s exercise of implementing powers. OJ L 55, 28/02/2011, p. 13–18, ELI:

http://data.europa.eu/eli/reg/2011/182/oj

(3) Standard rules of procedure for committees.

2

Please communicate their contact details by sending an email to SANTE-

[email protected] by 11 April 2025.

As the Commission services use AGM application (A new Gateway for EU Meetings) for

planning and organising meetings, the national authorities should also designate a specific

contact point (correspondent) for the Regulatory Committee. This correspondent will

receive the invitations to meetings and be responsible for the distribution of the invitation

to nominated representatives as well as for informing the Commission about the

participants for the meeting.

Please also find attached the draft Rules of Procedure of the Committee drawn up on the

basis of Standard rules of procedure for committees to be adopted at the first meeting.

The first meeting of the Committee is planned to take place virtually in June 2025.

Yours faithfully,

Sandra GALLINA

Contact: BAERT, Katleen, tel. +32 229-55981, [email protected]

Enclosure: Draft Rules of Procedure for the Regulatory Committee on standards of

quality and safety for substances of human origin

c.c.: L. BOIX ALONSO, R. BECKER, R. MCGEEHAN, L. BATTISTINI,

M. MOYA DIAZ, B. GAUTRAIS, M. CICCARELLO, S. VAN DER

SPIEGEL, M. AMBROSIO, K. BAERT, E. MARCHAND, R. PITEIRA

(SANTE)

Electronically signed on 19/03/2025 21:46 (UTC+01) in accordance with Article 11 of Commission Decision (EU) 2021/2121

To all Deputy Permanent Representatives of the EU Member States

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

The Director-General

Brussels SANTE.D.2/KB/eb/(2025) 2846059

By e-mail only

Subject: Nomination of representatives to the Regulatory Committee on

standards of quality and safety for substances of human origin

Your Excellency,

Regulation (EU) 2024/1938 on standards of quality and safety for substances of human

origin (SoHO) intended for human application (1) stipulates that the Commission shall

adopt an implementing act on the EU SoHO platform, as referred to in Article 74 of the

Regulation, at the latest by 7 August 2025, and the implementing acts as referred to in

Articles 41, 42, 43 and 48 at the latest by the date of application of this Regulation.

The Regulation provides that the Commission shall be assisted by a Committee, within the

meaning and with the tasks as laid down in Regulation (EU) No 182/2011 (2).

The members of the Regulatory Committee on standards of quality and safety for

substances of human origin shall be composed of representatives of the Member States.

Each Member State shall appoint their own representatives. In accordance with Regulation

(EU) No 182/2011, the Commission shall chair and provide the Secretariat of the

Committee. In accordance with Article 5(1) of the Standard rules of procedure for

committees (3), each Member State shall decide on the composition of its delegation and

inform the chair. With the chair's permission, the delegations may be accompanied by no

more than two experts who are not part of the delegation.

In view of the aforesaid, you are kindly invited to designate your representatives to the

Regulatory Committee on standards of quality and safety for substances of human origin.

(1) Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards

of quality and safety for substances of human origin intended for human application and repealing

Directives 2002/98/EC and 2004/23/EC. OJ L, 2024/1938, 17.7.2024, ELI:

http://data.europa.eu/eli/reg/2024/1938/oj

(2) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying

down the rules and general principles concerning mechanisms for control by Member States of the

Commission’s exercise of implementing powers. OJ L 55, 28/02/2011, p. 13–18, ELI:

http://data.europa.eu/eli/reg/2011/182/oj

(3) Standard rules of procedure for committees.

2

Please communicate their contact details by sending an email to SANTE-

[email protected] by 11 April 2025.

As the Commission services use AGM application (A new Gateway for EU Meetings) for

planning and organising meetings, the national authorities should also designate a specific

contact point (correspondent) for the Regulatory Committee. This correspondent will

receive the invitations to meetings and be responsible for the distribution of the invitation

to nominated representatives as well as for informing the Commission about the

participants for the meeting.

Please also find attached the draft Rules of Procedure of the Committee drawn up on the

basis of Standard rules of procedure for committees to be adopted at the first meeting.

The first meeting of the Committee is planned to take place virtually in June 2025.

Yours faithfully,

Sandra GALLINA

Contact: BAERT, Katleen, tel. +32 229-55981, [email protected]

Enclosure: Draft Rules of Procedure for the Regulatory Committee on standards of

quality and safety for substances of human origin

c.c.: L. BOIX ALONSO, R. BECKER, R. MCGEEHAN, L. BATTISTINI,

M. MOYA DIAZ, B. GAUTRAIS, M. CICCARELLO, S. VAN DER

SPIEGEL, M. AMBROSIO, K. BAERT, E. MARCHAND, R. PITEIRA

(SANTE)

Electronically signed on 19/03/2025 21:46 (UTC+01) in accordance with Article 11 of Commission Decision (EU) 2021/2121

EN 0 EN

RULES OF PROCEDURE FOR THE REGULATORY COMMITTEE ON

STANDARDS OF QUALITY AND SAFETY FOR SUBSTANCES OF HUMAN

ORIGIN

THE REGULATORY COMMITTEE ON STANDARDS OF QUALITY AND SAFETY FOR

SUBSTANCES OF HUMAN ORIGIN,

Having regard to Regulation (EU) 2024/1938 of the European Parliament and of the Council of

13 June 2024 on standards of quality and safety for substances of human origin intended for

human application and repealing Directives 2002/98/EC and 2004/23/EC1 and in particular

Article 79 thereof,

Having regard to Regulation (EU) No 182/2011 of the European Parliament and of the Council

of 16 February 2011 laying down the rules and general principles concerning mechanisms for

control by Member States of the Commission's exercise of implementing powers2, and in

particular Article 9(1) thereof,

Having regard to the standard rules of procedure published by the Commission3,

HAS ADOPTED THE FOLLOWING RULES OF PROCEDURE:

Article 1

Convening a meeting

1. A meeting of the committee shall be convened by the chair (a representative of the

Commission, as provided in Article 3(2) of Regulation (EU) No 182/2011), either on

their own initiative, or at the request of a simple majority of members of the committee.

2. In the case referred to in the second subparagraph of Article 3(5) of Regulation (EU)

No 182/2011, where the written procedure is terminated without result, the chair shall

convene a committee meeting within a reasonable time.

3. Joint meetings of the committee with other committees may be convened to discuss

issues coming within their respective areas of responsibility.

Article 2

Agenda

1. The chair shall draw up the agenda and submit it to the committee.

2. The agenda shall make a distinction between:

(a) draft implementing acts to be adopted by the Commission on which the committee

is asked to give an opinion, in accordance with the examination procedure

provided for in Article 79(2) of Regulation (EU) 2024/1938;

(b) other issues put to the committee for information or a simple exchange of views,

either on the chair's initiative, or at the written request of a member of the

committee.

1 OJ L, 2024/1938, 17.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1938/oj 2 OJ L 55, 28.2.2011, p 13. 3 OJ C 206, 12.7.2011, p. 11.

EN 1 EN

Article 3

Documentation to be submitted to members of the committee

1. For the purpose of the second subparagraph of Article 3(3) of Regulation (EU) No

182/2011, the chair shall submit the invitation, the draft agenda and the draft

implementing act on which the committee is asked to give an opinion to the members

of the committee well in advance of the meeting, taking into account the urgency and

the complexity of the matter, and no later than 14 calendar days before the date of the

meeting. Other documents related to the meeting, in particular documents

accompanying the draft implementing act, shall, as far as possible, be submitted within

the same time-limit.

All documents shall be submitted in accordance with Article 12(2).

2. In duly justified cases, the chair may, on their own initiative or at the request of a

member of the committee, shorten the time limit for submission of documents referred

to in paragraph 1. Except in cases of extreme urgency, the time limit shall not be shorter

than five calendar days.

Article 4

Opinion of the committee

1. The committee shall deliver its opinion on a draft implementing act within the time limit

laid down by the chair in accordance with the second subparagraph of Article 3(3) of

Regulation (EU) No 182/2011.

2. Where the committee's opinion is required under the examination procedure, the

outcome of the vote shall be decided by a qualified majority, in accordance with Article

5(1) of Regulation (EU) No 182/2011.

3. Unless a member of the committee objects, the chair may, without proceeding to a

formal vote, establish that the committee has delivered a positive opinion, by consensus,

on the draft implementing act.

4. The chair, in consultation with the members of the committee, may, on their own

initiative or at the request of a member of the committee, postpone a vote until the end

of the meeting or to a later meeting.

5. In accordance with the second subparagraph of Article 3(4) of Regulation (EU) No

182/2011, the chair shall endeavour to find solutions which command the widest

possible support within the committee. Before the vote, the chair shall inform the

committee of the manner in which the discussions and suggestions for amendments have

been taken into account, in particular as regards those suggestions which have been

largely supported within the committee.

Article 5

Representation

1. Each Member State shall be considered to be one member of the committee. Each

member of the committee shall decide on the composition of its delegation and inform

the chair. With the chair's permission, the delegations may be accompanied by experts

who are not part of the delegation.

2. Within a reasonable time and no later than five calendar days before the date of a

committee meeting, the following information shall be communicated to the chair:

EN 2 EN

a) The composition of each delegation, except where such composition is already

known to the chair;

b) names and functions of any experts accompanying the delegations and the reasons

for which their presence is required.

If the chair does not object to the participation of an expert in advance of the committee

meeting, the permission referred to in paragraph 1 is considered to be granted.

3. The reimbursement of travel expenses by the Commission shall be paid in accordance

with the applicable rules, subject to budgetary funds provided for this purpose.

4. A Member State delegation may represent a maximum of one other Member State. The

Member State that is being represented shall inform the chair of this before the meeting,

or, at the latest, before the vote.

Article 6

Working groups

1. The committee may create working groups to examine particular issues. The working

groups shall be chaired by a representative of the Commission.

2. The working groups shall report back to the committee under the responsibility of their

chair.

Article 7

Third parties and experts

1. The representatives of third countries or organisations who are entitled by a binding

legal act to be present in the committee meeting shall be invited to attend the meetings

of the committee in accordance with the respective legal act.

2. Representatives of acceding countries shall be invited to attend the meetings of the

committee as from the date of signature of the Treaty of Accession.

3. The chair may decide to invite representatives of other third parties or other experts to

talk on particular matters, on their own initiative or at the request of a member of the

committee. However, a simple majority of the component members of the committee

may oppose their participation in the meeting.

4. Representatives of third parties and experts referred to in paragraphs 1, 2 and 3 shall not

be present at and shall not participate in voting of the committee.

Article 8

Written procedure

1. The chair may obtain the committee's opinion by written procedure in accordance with

Article 3(5) of Regulation (EU) No 182/2011. In particular, the chair may use the written

procedure to obtain the committee's opinion in cases where the draft implementing act

has already been discussed during a committee meeting.

2. The chair shall inform the members of the committee of the outcome of the written

procedure without delay, and no later than 14 calendar days after the expiry of the time

limit.

EN 3 EN

Article 9

Secretarial support

The Commission shall provide secretarial support for the committee and, if necessary, the

working groups created pursuant to Article 6(1).

Article 10

Minutes and summary record of meetings

1. For the purpose of Article 3(6) of Regulation (EU) No 182/2011, the minutes of each

meeting shall be drawn up under the responsibility of the chair. Committee members

shall have the right to ask for their position to be recorded in the minutes. The chair shall

send the minutes to the committee members without delay and no later than one month

after the meeting.

The members of the committee shall send any comments they may have on the draft

minutes to the chair in writing. If there is any disagreement, the matter shall be discussed

by the committee. If the disagreement persists, the relevant comments shall be annexed

to the final minutes.

2. For the purpose of Article 10 of Regulation (EU) No 182/2011, the chair shall be

responsible for drawing up a summary record briefly describing each item on the agenda

and the results of the vote on any draft implementing act submitted to the committee.

The summary record shall not mention the individual position of the members in the

committee's discussions.

Article 11

Attendance list and conflicts of interest

1. At each meeting, the chair shall draw up an attendance list specifying the authorities

and organisations to which the persons designated by the Member States to represent

them belong.

2. At the beginning of each meeting, any person designated by the Member States, as well

as experts who have been authorised by the chair to participate in the meeting in

accordance with Article 5(1) and Article 7(3), and representatives of third parties who

have been invited to attend the meeting in accordance with Article 7, shall inform the

chair of any conflict of interest4 with regard to a particular item on the agenda.

In the event of such a conflict of interest, the person concerned shall, at the request of

the chair, withdraw from the meeting whilst the relevant items of the agenda are being

dealt with.

Article 12

Correspondence

1. Correspondence relating to the committee shall be submitted to the Commission, for the

attention of the chair of the committee.

4 As an example, Article 61(3) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of

the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending

Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU)

No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No

541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30/07/2018,, p. 1)

contains a specific definition of a conflict of interest.

EN 4 EN

2. Correspondence for members of the committee shall be submitted to the Permanent

Representations of the Member States, preferably by electronic means. Where a

Permanent Representation indicates to the Commission a specific central electronic

address for correspondence related to work of the committees, that address shall be used

for correspondence. In addition, correspondence may be submitted directly to the

persons designated by the Member States to represent them in the committee.

Article 13

Access to documents and confidentiality

1. Requests for access to committee documents shall be handled in accordance with

Regulation (EC) No 1049/2001 of the European Parliament and of the Council5. It is for

the Commission to take a decision on requests for access to those documents pursuant

to its Rules of Procedure as amended by Decision 2001/937/EC, ECSC, Euratom6. If

the request is addressed to a Member State that Member State shall apply Article 5 of

Regulation (EC) No 1049/2001.

2. The committee's discussions shall be confidential.

3. Documents submitted to members of the committee, experts and representatives of third

parties shall be confidential7, unless access is granted to those documents pursuant to

paragraph 1 or they are otherwise made public by the Commission.

4. The members of the committee, as well as experts and representatives of third parties,

shall be required to respect the confidentiality obligations set out in this Article. The

chair shall ensure that experts and representatives of third parties are made aware of the

confidentiality requirements imposed upon them.

Article 14

Protection of personal data

The processing of personal data by the committee and its working groups shall be in conformity

with Regulation (EU) 2018/1725 of the European Parliament and of the Council8, under the

responsibility of the chair acting as a controller, within the meaning of point (8) of Article 3 of

that Regulation.

5 OJ L 145, 31.5.2001 p. 43. 6 OJ L 345, 29.12.2001, p. 94. 7 In accordance with Article 339 TFEU, "[t]he members of the institutions of the Union, the members of

committees, and the officials and other servants of the Union shall be required, even after their duties

have ceased, not to disclose information of the kind covered by the obligation of professional secrecy, in

particular information about undertakings, their business relations or their cost components". 8 OJ L 295, 21.11.2018, p. 39–98.

EN 0 EN

RULES OF PROCEDURE FOR THE REGULATORY COMMITTEE ON

STANDARDS OF QUALITY AND SAFETY FOR SUBSTANCES OF HUMAN

ORIGIN

THE REGULATORY COMMITTEE ON STANDARDS OF QUALITY AND SAFETY FOR

SUBSTANCES OF HUMAN ORIGIN,

Having regard to Regulation (EU) 2024/1938 of the European Parliament and of the Council of

13 June 2024 on standards of quality and safety for substances of human origin intended for

human application and repealing Directives 2002/98/EC and 2004/23/EC1 and in particular

Article 79 thereof,

Having regard to Regulation (EU) No 182/2011 of the European Parliament and of the Council

of 16 February 2011 laying down the rules and general principles concerning mechanisms for

control by Member States of the Commission's exercise of implementing powers2, and in

particular Article 9(1) thereof,

Having regard to the standard rules of procedure published by the Commission3,

HAS ADOPTED THE FOLLOWING RULES OF PROCEDURE:

Article 1

Convening a meeting

1. A meeting of the committee shall be convened by the chair (a representative of the

Commission, as provided in Article 3(2) of Regulation (EU) No 182/2011), either on

their own initiative, or at the request of a simple majority of members of the committee.

2. In the case referred to in the second subparagraph of Article 3(5) of Regulation (EU)

No 182/2011, where the written procedure is terminated without result, the chair shall

convene a committee meeting within a reasonable time.

3. Joint meetings of the committee with other committees may be convened to discuss

issues coming within their respective areas of responsibility.

Article 2

Agenda

1. The chair shall draw up the agenda and submit it to the committee.

2. The agenda shall make a distinction between:

(a) draft implementing acts to be adopted by the Commission on which the committee

is asked to give an opinion, in accordance with the examination procedure

provided for in Article 79(2) of Regulation (EU) 2024/1938;

(b) other issues put to the committee for information or a simple exchange of views,

either on the chair's initiative, or at the written request of a member of the

committee.

1 OJ L, 2024/1938, 17.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1938/oj 2 OJ L 55, 28.2.2011, p 13. 3 OJ C 206, 12.7.2011, p. 11.

EN 1 EN

Article 3

Documentation to be submitted to members of the committee

1. For the purpose of the second subparagraph of Article 3(3) of Regulation (EU) No

182/2011, the chair shall submit the invitation, the draft agenda and the draft

implementing act on which the committee is asked to give an opinion to the members

of the committee well in advance of the meeting, taking into account the urgency and

the complexity of the matter, and no later than 14 calendar days before the date of the

meeting. Other documents related to the meeting, in particular documents

accompanying the draft implementing act, shall, as far as possible, be submitted within

the same time-limit.

All documents shall be submitted in accordance with Article 12(2).

2. In duly justified cases, the chair may, on their own initiative or at the request of a

member of the committee, shorten the time limit for submission of documents referred

to in paragraph 1. Except in cases of extreme urgency, the time limit shall not be shorter

than five calendar days.

Article 4

Opinion of the committee

1. The committee shall deliver its opinion on a draft implementing act within the time limit

laid down by the chair in accordance with the second subparagraph of Article 3(3) of

Regulation (EU) No 182/2011.

2. Where the committee's opinion is required under the examination procedure, the

outcome of the vote shall be decided by a qualified majority, in accordance with Article

5(1) of Regulation (EU) No 182/2011.

3. Unless a member of the committee objects, the chair may, without proceeding to a

formal vote, establish that the committee has delivered a positive opinion, by consensus,

on the draft implementing act.

4. The chair, in consultation with the members of the committee, may, on their own

initiative or at the request of a member of the committee, postpone a vote until the end

of the meeting or to a later meeting.

5. In accordance with the second subparagraph of Article 3(4) of Regulation (EU) No

182/2011, the chair shall endeavour to find solutions which command the widest

possible support within the committee. Before the vote, the chair shall inform the

committee of the manner in which the discussions and suggestions for amendments have

been taken into account, in particular as regards those suggestions which have been

largely supported within the committee.

Article 5

Representation

1. Each Member State shall be considered to be one member of the committee. Each

member of the committee shall decide on the composition of its delegation and inform

the chair. With the chair's permission, the delegations may be accompanied by experts

who are not part of the delegation.

2. Within a reasonable time and no later than five calendar days before the date of a

committee meeting, the following information shall be communicated to the chair:

EN 2 EN

a) The composition of each delegation, except where such composition is already

known to the chair;

b) names and functions of any experts accompanying the delegations and the reasons

for which their presence is required.

If the chair does not object to the participation of an expert in advance of the committee

meeting, the permission referred to in paragraph 1 is considered to be granted.

3. The reimbursement of travel expenses by the Commission shall be paid in accordance

with the applicable rules, subject to budgetary funds provided for this purpose.

4. A Member State delegation may represent a maximum of one other Member State. The

Member State that is being represented shall inform the chair of this before the meeting,

or, at the latest, before the vote.

Article 6

Working groups

1. The committee may create working groups to examine particular issues. The working

groups shall be chaired by a representative of the Commission.

2. The working groups shall report back to the committee under the responsibility of their

chair.

Article 7

Third parties and experts

1. The representatives of third countries or organisations who are entitled by a binding

legal act to be present in the committee meeting shall be invited to attend the meetings

of the committee in accordance with the respective legal act.

2. Representatives of acceding countries shall be invited to attend the meetings of the

committee as from the date of signature of the Treaty of Accession.

3. The chair may decide to invite representatives of other third parties or other experts to

talk on particular matters, on their own initiative or at the request of a member of the

committee. However, a simple majority of the component members of the committee

may oppose their participation in the meeting.

4. Representatives of third parties and experts referred to in paragraphs 1, 2 and 3 shall not

be present at and shall not participate in voting of the committee.

Article 8

Written procedure

1. The chair may obtain the committee's opinion by written procedure in accordance with

Article 3(5) of Regulation (EU) No 182/2011. In particular, the chair may use the written

procedure to obtain the committee's opinion in cases where the draft implementing act

has already been discussed during a committee meeting.

2. The chair shall inform the members of the committee of the outcome of the written

procedure without delay, and no later than 14 calendar days after the expiry of the time

limit.

EN 3 EN

Article 9

Secretarial support

The Commission shall provide secretarial support for the committee and, if necessary, the

working groups created pursuant to Article 6(1).

Article 10

Minutes and summary record of meetings

1. For the purpose of Article 3(6) of Regulation (EU) No 182/2011, the minutes of each

meeting shall be drawn up under the responsibility of the chair. Committee members

shall have the right to ask for their position to be recorded in the minutes. The chair shall

send the minutes to the committee members without delay and no later than one month

after the meeting.

The members of the committee shall send any comments they may have on the draft

minutes to the chair in writing. If there is any disagreement, the matter shall be discussed

by the committee. If the disagreement persists, the relevant comments shall be annexed

to the final minutes.

2. For the purpose of Article 10 of Regulation (EU) No 182/2011, the chair shall be

responsible for drawing up a summary record briefly describing each item on the agenda

and the results of the vote on any draft implementing act submitted to the committee.

The summary record shall not mention the individual position of the members in the

committee's discussions.

Article 11

Attendance list and conflicts of interest

1. At each meeting, the chair shall draw up an attendance list specifying the authorities

and organisations to which the persons designated by the Member States to represent

them belong.

2. At the beginning of each meeting, any person designated by the Member States, as well

as experts who have been authorised by the chair to participate in the meeting in

accordance with Article 5(1) and Article 7(3), and representatives of third parties who

have been invited to attend the meeting in accordance with Article 7, shall inform the

chair of any conflict of interest4 with regard to a particular item on the agenda.

In the event of such a conflict of interest, the person concerned shall, at the request of

the chair, withdraw from the meeting whilst the relevant items of the agenda are being

dealt with.

Article 12

Correspondence

1. Correspondence relating to the committee shall be submitted to the Commission, for the

attention of the chair of the committee.

4 As an example, Article 61(3) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of

the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending

Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU)

No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No

541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30/07/2018,, p. 1)

contains a specific definition of a conflict of interest.

EN 4 EN

2. Correspondence for members of the committee shall be submitted to the Permanent

Representations of the Member States, preferably by electronic means. Where a

Permanent Representation indicates to the Commission a specific central electronic

address for correspondence related to work of the committees, that address shall be used

for correspondence. In addition, correspondence may be submitted directly to the

persons designated by the Member States to represent them in the committee.

Article 13

Access to documents and confidentiality

1. Requests for access to committee documents shall be handled in accordance with

Regulation (EC) No 1049/2001 of the European Parliament and of the Council5. It is for

the Commission to take a decision on requests for access to those documents pursuant

to its Rules of Procedure as amended by Decision 2001/937/EC, ECSC, Euratom6. If

the request is addressed to a Member State that Member State shall apply Article 5 of

Regulation (EC) No 1049/2001.

2. The committee's discussions shall be confidential.

3. Documents submitted to members of the committee, experts and representatives of third

parties shall be confidential7, unless access is granted to those documents pursuant to

paragraph 1 or they are otherwise made public by the Commission.

4. The members of the committee, as well as experts and representatives of third parties,

shall be required to respect the confidentiality obligations set out in this Article. The

chair shall ensure that experts and representatives of third parties are made aware of the

confidentiality requirements imposed upon them.

Article 14

Protection of personal data

The processing of personal data by the committee and its working groups shall be in conformity

with Regulation (EU) 2018/1725 of the European Parliament and of the Council8, under the

responsibility of the chair acting as a controller, within the meaning of point (8) of Article 3 of

that Regulation.

5 OJ L 145, 31.5.2001 p. 43. 6 OJ L 345, 29.12.2001, p. 94. 7 In accordance with Article 339 TFEU, "[t]he members of the institutions of the Union, the members of

committees, and the officials and other servants of the Union shall be required, even after their duties

have ceased, not to disclose information of the kind covered by the obligation of professional secrecy, in

particular information about undertakings, their business relations or their cost components". 8 OJ L 295, 21.11.2018, p. 39–98.

To all Deputy Permanent Representatives of the EU Member States

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

The Director-General

Brussels SANTE.D.2/KB/eb/(2025) 2846059

By e-mail only

Subject: Nomination of representatives to the Regulatory Committee on

standards of quality and safety for substances of human origin

Your Excellency,

Regulation (EU) 2024/1938 on standards of quality and safety for substances of human

origin (SoHO) intended for human application (1) stipulates that the Commission shall

adopt an implementing act on the EU SoHO platform, as referred to in Article 74 of the

Regulation, at the latest by 7 August 2025, and the implementing acts as referred to in

Articles 41, 42, 43 and 48 at the latest by the date of application of this Regulation.

The Regulation provides that the Commission shall be assisted by a Committee, within the

meaning and with the tasks as laid down in Regulation (EU) No 182/2011 (2).

The members of the Regulatory Committee on standards of quality and safety for

substances of human origin shall be composed of representatives of the Member States.

Each Member State shall appoint their own representatives. In accordance with Regulation

(EU) No 182/2011, the Commission shall chair and provide the Secretariat of the

Committee. In accordance with Article 5(1) of the Standard rules of procedure for

committees (3), each Member State shall decide on the composition of its delegation and

inform the chair. With the chair's permission, the delegations may be accompanied by no

more than two experts who are not part of the delegation.

In view of the aforesaid, you are kindly invited to designate your representatives to the

Regulatory Committee on standards of quality and safety for substances of human origin.

(1) Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards

of quality and safety for substances of human origin intended for human application and repealing

Directives 2002/98/EC and 2004/23/EC. OJ L, 2024/1938, 17.7.2024, ELI:

http://data.europa.eu/eli/reg/2024/1938/oj

(2) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying

down the rules and general principles concerning mechanisms for control by Member States of the

Commission’s exercise of implementing powers. OJ L 55, 28/02/2011, p. 13–18, ELI:

http://data.europa.eu/eli/reg/2011/182/oj

(3) Standard rules of procedure for committees.

2

Please communicate their contact details by sending an email to SANTE-

[email protected] by 11 April 2025.

As the Commission services use AGM application (A new Gateway for EU Meetings) for

planning and organising meetings, the national authorities should also designate a specific

contact point (correspondent) for the Regulatory Committee. This correspondent will

receive the invitations to meetings and be responsible for the distribution of the invitation

to nominated representatives as well as for informing the Commission about the

participants for the meeting.

Please also find attached the draft Rules of Procedure of the Committee drawn up on the

basis of Standard rules of procedure for committees to be adopted at the first meeting.

The first meeting of the Committee is planned to take place virtually in June 2025.

Yours faithfully,

Sandra GALLINA

Contact: BAERT, Katleen, tel. +32 229-55981, [email protected]

Enclosure: Draft Rules of Procedure for the Regulatory Committee on standards of

quality and safety for substances of human origin

c.c.: L. BOIX ALONSO, R. BECKER, R. MCGEEHAN, L. BATTISTINI,

M. MOYA DIAZ, B. GAUTRAIS, M. CICCARELLO, S. VAN DER

SPIEGEL, M. AMBROSIO, K. BAERT, E. MARCHAND, R. PITEIRA

(SANTE)

Electronically signed on 19/03/2025 21:46 (UTC+01) in accordance with Article 11 of Commission Decision (EU) 2021/2121

To all Deputy Permanent Representatives of the EU Member States

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

The Director-General

Brussels SANTE.D.2/KB/eb/(2025) 2846059

By e-mail only

Subject: Nomination of representatives to the Regulatory Committee on

standards of quality and safety for substances of human origin

Your Excellency,

Regulation (EU) 2024/1938 on standards of quality and safety for substances of human

origin (SoHO) intended for human application (1) stipulates that the Commission shall

adopt an implementing act on the EU SoHO platform, as referred to in Article 74 of the

Regulation, at the latest by 7 August 2025, and the implementing acts as referred to in

Articles 41, 42, 43 and 48 at the latest by the date of application of this Regulation.

The Regulation provides that the Commission shall be assisted by a Committee, within the

meaning and with the tasks as laid down in Regulation (EU) No 182/2011 (2).

The members of the Regulatory Committee on standards of quality and safety for

substances of human origin shall be composed of representatives of the Member States.

Each Member State shall appoint their own representatives. In accordance with Regulation

(EU) No 182/2011, the Commission shall chair and provide the Secretariat of the

Committee. In accordance with Article 5(1) of the Standard rules of procedure for

committees (3), each Member State shall decide on the composition of its delegation and

inform the chair. With the chair's permission, the delegations may be accompanied by no

more than two experts who are not part of the delegation.

In view of the aforesaid, you are kindly invited to designate your representatives to the

Regulatory Committee on standards of quality and safety for substances of human origin.

(1) Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards

of quality and safety for substances of human origin intended for human application and repealing

Directives 2002/98/EC and 2004/23/EC. OJ L, 2024/1938, 17.7.2024, ELI:

http://data.europa.eu/eli/reg/2024/1938/oj

(2) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying

down the rules and general principles concerning mechanisms for control by Member States of the

Commission’s exercise of implementing powers. OJ L 55, 28/02/2011, p. 13–18, ELI:

http://data.europa.eu/eli/reg/2011/182/oj

(3) Standard rules of procedure for committees.

2

Please communicate their contact details by sending an email to SANTE-

[email protected] by 11 April 2025.

As the Commission services use AGM application (A new Gateway for EU Meetings) for

planning and organising meetings, the national authorities should also designate a specific

contact point (correspondent) for the Regulatory Committee. This correspondent will

receive the invitations to meetings and be responsible for the distribution of the invitation

to nominated representatives as well as for informing the Commission about the

participants for the meeting.

Please also find attached the draft Rules of Procedure of the Committee drawn up on the

basis of Standard rules of procedure for committees to be adopted at the first meeting.

The first meeting of the Committee is planned to take place virtually in June 2025.

Yours faithfully,

Sandra GALLINA

Contact: BAERT, Katleen, tel. +32 229-55981, [email protected]

Enclosure: Draft Rules of Procedure for the Regulatory Committee on standards of

quality and safety for substances of human origin

c.c.: L. BOIX ALONSO, R. BECKER, R. MCGEEHAN, L. BATTISTINI,

M. MOYA DIAZ, B. GAUTRAIS, M. CICCARELLO, S. VAN DER

SPIEGEL, M. AMBROSIO, K. BAERT, E. MARCHAND, R. PITEIRA

(SANTE)

Electronically signed on 19/03/2025 21:46 (UTC+01) in accordance with Article 11 of Commission Decision (EU) 2021/2121