EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2014) XXX  draft 
  
COMMISSION DIRECTIVE ../…/EU 
of XXX  
amending Directive 2006/86/EC as regards certa in technical requirements for the coding 
of human tissues and cells 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION DIRECTIVE ../…/EU 
of XXX  
amending Directive 2006/86/EC as regards cert ain technical requirements for the coding 
of human tissues and cells 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Directive 2004/23/EC of the Eu ropean Parliament and of the Council of 31 
March 2004 on setting standards of quality and safety for the donation, procurement, testing, 
processing, preservation, storage and distribution of human tissues  and cells, and in particular 
Article 28 thereof, 
Whereas: (1) Directive 2004/23/EC requires that Member States ensure  the traceability of human 
tissues and cells from the donor to the recipient and vice-versa.    
(2) In order to facilitate  traceability it is necessary to establish a unique identifier applied 
to tissues and cells distributed in the Union (“Single European Code”) providing 
information on the main characteristics a nd properties of those tissues and cells. 
(3) In order to ensure a uniform implementati on of the Single European Code throughout 
the Union, obligations of the Member States  competent authoritie s and of the tissue 
establishments for the applic ation of the Single European Code should be set out. Only 
this approach will guarantee a consistent a nd coherent application of the code in the 
Union.   
(4) Traceability from donor to recipient and vice-versa should be ensured through coding 
of tissues and cells and through accompa nying documentation. At the recipient end, 
the Single European Code provides info rmation on the donation and on the tissue 
establishment responsible for the procuremen t of tissues and cells. At the donor end, 
the tissue establishment responsible for the procurement of tissues and cells may track 
the tissues and cells distributed for human application by requesti ng the next operators 
in the chain to provide data related to th e use of the tissues and cells based on the 
donation identification elements of the Singl e European Code as contained in the 
accompanying documentation. 
(5) A Single European Code allowing for dona tion and product identif ication should be 
allocated to all tissues a nd cells distributed for human  application, including those 
imported from third countries. Member States may allow certain exemptions from the application of the code.  
(6) In situations where tissues and cells are released for circulation, other than for 
distribution, such as transfer  to another operator for furthe r processing with or without 
return, as a minimum the donation identific ation should be applie d at least in the 
accompanying documentation. Where tissues a nd cells are transferred from a tissue  
EN 3   EN establishment to another operator just for storage and/or for fu rther distribution, the 
tissue establishment may already apply the Si ngle European Code on their final label. 
(7) In case of tissues and cells retrieved from a deceased donor by procurement teams 
operating for two or more tissue establishm ents, Member States shall ensure an 
appropriate traceability system across pr ocurements. This may be ensured by 
developing a central system for the alloca tion of the unique donation numbers for each 
donation event recorded at nati onal level, or by requiring all tissue establishments to 
ensure the appropriate links between the donation identification numbers allocated by 
each tissue establishment procuring or receiv ing tissue and cells originating from the 
same deceased donor.   
(8) The format of the Single European Code shoul d be harmonised in orde r to facilitate its 
application by small and large establishments, whilst allowing some flexibility for establishments to contin ue using existing codes. 
(9) The Commission should ensure the implemen tation of the Single European Code by 
providing the appropriate tools to the Member States competent authorities and tissue 
establishments. The Member States compet ent authorities should update the register 
for tissue establishments, reflecting any cha nges in tissue establishment accreditations, 
designations, authorisations, or licenses and the Commissi on should ensure the update 
of the register of the tissues and cells when ever new products need to be included. For 
this the Commission may consu lt a group of experts,  in particular experts nominated 
by the Member States competent authorities. 
(10) For the donation identification in the Si ngle European Code, the importing tissue 
establishment should use the ti ssue establishment code allocat ed to it in the EU Tissue 
Establishment Compendium and should a llocate a unique donation number if the 
donation number on the imported product is not globally unique. 
(11) A transitional regime for tissues and cells  already in storage at the end of the 
transposition period sh ould be introduced. 
(12) This Directive does not prevent Member Stat es from maintaining or introducing more 
stringent measures relating to coding of tissues and cells, provided that the provisions 
of the Treaty are met. 
(13) The measures provided for in this Directiv e are in accordance with the opinion of the 
Committee established by Article 29 of Directive 2004/23/EC,  
 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Directive 2006/86/EC is he reby amended as follows: 
(1) In Article 2, the following points (k) to (y) are added: 
(k) “tissues and cells” means for the purpos e of this Directive all substances of 
human origin falling within the scope of this Directive as set out in Article 1 
paragraph 1;  
(l) “Single European Code” or “SEC” mean s the unique identifier applied to tissues 
and cells distributed in th e Union. The Single European Code consists of a 
donation identification sequence and a product identificati on sequence, as 
further specified in Annex VII to this Directive;   
EN 4   EN (m) “donation identification sequence” means th e first part of the Single European 
Code consisting of the tissue establishment code and the unique donation number; 
(n) “EU tissue establishment code” mean s the unique identifier for accredited, 
designated authorised, or lic ensed tissue establishments  in the Union. The tissue 
establishment code consists of an ISO country code and the tissue establishment 
number set out in the EU Tissue Es tablishment Compendium, as further 
specified in Annex VII to this Directive; 
(o) “unique donation number” means the uni que number attributed to a specific 
donation of tissues and cells in line with the system in place in each Member State for allocating such numbers, as fu rther specified in Annex VII to this 
Directive;  
(p) “product identification sequence” means the second part of the Single European 
Code consisting of the product code, the split number and the expiry date;  
(q) “product code” means the identifier for the specific type of tissue and cell in 
question. The product code consists of the product coding system identifier 
indicating the coding system used by th e tissue establishment (“E” for the 
EUTC, “A” for ISBT128, “B” for Eurocode  ) and the tissues and cells product 
number foreseen in the respective coding system for the product type, as further 
defined in Annex VII to this Directive; 
(r) “split number” means the number which distinguishes and uniquely identifies 
tissues and cells having the same unique donation number and the same product code and originating from the same tissu e establishment, as further defined in 
Annex VII to this Directive; 
(s) “expiry date” means the da te by which the tissues a nd cells can be applied, as 
further defined in Annex VII to this Directive;  
(t) “EU Coding Platform” means the IT pl atform hosted by the Commission which 
contains the EU Tissue Establishment Compendium and the EU Tissue and Cell 
Product Compendium;   
(u) “EU Tissue Establishment Compendium ” means the register of all tissue 
establishments which are authorised, licensed, designated or  accredited by the 
Member States’ competent authority or authorities and which contains the information about these tissue establishmen ts as set out in A nnex VIII to this 
Directive; 
(v) “EU Tissue and Cell Product Compendium ” means the register of all types of 
tissues and cells circulating in the Un ion and the respective product codes under 
the three permitted coding systems (EUTC, ISBT128 and Eurocode); 
(w) “EUTC" means the product coding system  for tissues and cells developed by the 
Union consisting of a register  of all types of tissues a nd cells circulating in the 
Union and their corresponding product codes.   
(x) “released for circulation” means distribu tion for human application or transfer to 
another operator e.g. for further pr ocessing with or without return. 
(y) “within the same centre” means that all steps from procurement to human 
application are carried out within a heal thcare facility comp rising at least an  
EN 5   EN accredited, designated, authorised, or licensed tissue establishment and an 
organisation responsible for human a pplication at the same location; 
 (2) Article 9 is replaced by the following:  
“Article 9 
Traceability  
1. Member States shall ensure that tissues a nd cells shall be trace able in particular 
through documentation and the use of the Singl e European Code from procurement to 
human application or disposal and vice vers a. Tissues and cells used for advanced 
therapy medicinal products shall be traceab le under this Direc tive at least until 
transferred to the ATMP manufacturer.  
2. Member States shall ensure that tissue establishments and organisations responsible 
for human application shall retain the data set out in Annex VI for at least 30 years, 
using an appropriate and readable storage medium.  
In case of tissues and cells retrieved from a deceased donor by procurement teams 
operating for two or more tissue establishm ents, Member States shall ensure an 
appropriate traceability system across the procurements.”  
 (3) Article 10 is replaced by the following:  
“Article 10 
European coding system  
 
1. Without prejudice to paragraphs 2 or 3 of this Article, a Single European Code shall 
be applied to all tissue and cells distri buted for human application. For the other 
situations where tissues and cells are re leased for circulation, as a minimum the 
donation identification sequence shall be ap plied at least in the accompanying 
documentation. 
2. Paragraph 1 shall not apply to:  
(a) reproductive cells from partner donation, when  such cells remain within the same 
centre; 
(b) tissues and cells distributed di rectly for immediate transplant ation to the recipient, as 
referred to in Article 6( 5) of Directive 2004/23/EC. 
3. Member States may also allow exemptions  from the requirement provided for in 
paragraph 1 for: 
(a) tissues and cells other than reproductive ce lls for partner donation, when these tissues 
and cells remain within the same centre;  
(b) tissues and cells that are imported into the Union, when these tissues and cells remain 
within the same healthcare fa cility from importation to appl ication, provided that the  
EN 6   EN healthcare facility comprises the tissue establishment authorised, designated, 
accredited, or licensed to carry out importing activities.” 
 (4) The following Articles are inserted: 
“Article 10a 
Format of the Single European Code 
1. The Single European Code referred to in  Article 10(1) shall comply with the 
specifications set out in this Article and in Annex VII.  
2. The Single European Code shall be in eye- readable format and shall be preceded by 
the acronym “SEC”. The parallel use of ot her labelling and traceability systems is 
possible.   
3. The Single European Code shall be printe d with the Donation Identification Sequence 
and Product Identification Sequence separate d by a single space or as two successive 
lines.   
 
 Article 10b  
Requirements related to the applicati on of the Single European Code  
1. Member States shall ensure that the fo llowing minimum requirements are applied by  
tissue establishments, including those impor ting tissues and cells into the Union: 
(a) allocate a Single European Code to all ti ssues and cells requiring application of 
this code at the latest before thei r distribution for human application;  
(b) allocate a donation identification sequence  after procuring the tissues and cells, or 
when receiving them from a procurement organisation, or when importing tissues and cells from a third country supplier . The donation identification sequence shall 
include: 
(i) their EU tissue establishment c ode as assigned in the EU Tissue 
Establishment Compendium; 
(ii) a unique donation number allocated by the tissue establishment, unless such 
number is allocated centrally at national level or is a globally unique number;  
(c) do not alter the donation iden tification sequence once it is allocated to tissues and 
cells released for circulati on, unless it is necessary to correct an encoding error; 
any correction requires proper documentation;  
(d) use one of the authorised product codi ng systems and the corresponding tissue 
and cell product numbers included in the EU Tissue and Cell Product Compendium at the latest before thei r distribution for human application;  
EN 7   EN (e) use an appropriate split number and expiry  date. For tissues an d cells for which no 
expiry date is defined, the expiry date shall be 00000000 at the latest before their 
distribution for human application; 
(f) apply the Single European Code on the label of the product concerned in an 
indelible and permanent manner and me ntion that code in the relevant 
accompanying documentation at the latest before their distribution for human 
application. The tissue establishment may entr ust this task to a third party or third 
parties, provided the tissue establishmen t ensures compliance with this Directive, 
in particular in terms of uniqueness of the code. Where the label size precludes the 
application of the Single European C ode on the label, the code shall be 
unambiguously linked to tissues  and cells packaged with  such a label through the 
accompanying documentation; 
(g) alert the competent author ity or authorities when: 
(i) information contained in the EU Tissue Establishment Compendium 
requires an update or correction,   
(ii) the EU Tissue and Cell Produc t Compendium requires an update, 
(iii) the tissue establishment observes a situation of significant non-compliance 
with the requirements relating to  the Single European Code.    
2. Member States shall ensure that the fo llowing minimum requirements are applied by 
all competent authorities: 
(a) ensure the allocation of a unique tissu e establishment number to all tissue 
establishments authorised, accredited, designa ted or licensed in its Member State. 
If a tissue establishment has different phys ical locations, but has one system for 
allocating unique donation numbers, it may be deemed to be one and the same 
tissue establishment. If a tissue establishment uses two or more systems to allocate unique donation numbers, such an entity shall be allo cated separate tissue 
establishment numbers corresponding to th e number of allocation systems used;  
(b) decide which system or systems shall be used for the allocation of unique 
donation numbers in their Member State. Permitted systems of allocation include national systems establishing centralised allocation of the uni que donation number 
or systems requiring each tissue esta blishment to allocate unique donation 
numbers or international systems that  allocate globally unique donation numbers 
that are compatible with the Single European Code. 
(c) monitor and enforce the full implementation of the Single European Code in their 
Member State; 
(d) verify whether the data on the tissue es tablishments contained in the EU Tissue 
Establishment Compendium for their Memb er State is correct and update the 
Compendium without undue delay in part icular in the following situations:  
i. When a new tissue establishment is authorised, designa ted, accredited, 
or licensed; 
ii. When tissue establishment information changes or is not correctly 
recorded in the EU Tissue Establishment Compendium;  
iii. When the accreditation, designation, aut horisation or licen se details of a 
tissue establishment, as listed in Annex IX to this Directive, change, 
including:  
EN 8   EN – Accreditation, designation, authorisation or license for a new tissue or 
cell type; 
– Accreditation, designation, authorisation or license for a new prescribed 
activity; 
– Details of any conditions and or exemp tions added to an authorisation;  
– Suspension, in part or in full, of  a specific accred itation, designation, 
authorisation or license for a particular activity or tissue or cell type; 
– Revocation, in part or in full, of an accreditat ion, designation, 
authorisation or license for a tissue establishment; 
– Situations when a tissue establishment voluntarily ceases, in part or in 
full, the activity or activities for which it is authorised, accredited, designated or licensed. 
Undue delay means in not later than five working days for any changes substantially 
affecting the authorisati on, accreditation, designation or license of the tissue 
establishments concerned.  
When a tissue establishment is authorised by two or more competent authorities for 
different types of tissues and cells or di fferent activities, each  competent authority 
shall update the information relating to those activities for which it is responsible;  
(e) Alert the competent authorities of anot her Member State when they observe 
incorrect information in the EU Tissue Establishment Compendium relating to the 
other Member State or when they obs erve a situation of significant non-
compliance with the provisions relating to the Single European Code relating to the other Member State; 
(f) Alert the Commission and the other Competent Authorities when in their 
assessment the EU Tissue and Cell Product Compendium requires an update.” 
3. The application of the Single European  Code does not preclude the additional 
application of other codes in  accordance with Member States' national requirements.” 
 
 Article 10c 
Accessibility and maintenance of the European coding system  
1. The Commission shall host and maintain an  IT platform (“EU Coding Platform”) 
which contains:  
(a) the  EU Tissues Establishment Compendium; 
(b) the EU Tissue and Cell Product Compendium.  
2. The Commission shall ensure that the in formation contained in the EU Coding 
Platform is publicly available. 
3. The Commission shall update when needed th e EUTC and ensure the overall update of 
the EU Tissue and Cell Product Compendium. If organisations managing the ISBT128 
or Eurocode product coding systems do not submit the proposals for the appropriate update of the product codes, the Commissi on may suspend the use of the respective  
EN 9   EN coding system and if the proposal for an upda te is not submitted within three months 
following the suspension the Commission may prohibit the future use of the respective 
code. 
 
 Article 10d  
Transitional period 
Tissues and cells in storage on […]1 shall be exempted from th e obligations relating to the 
Single European Code, provided th e tissues and cells are released  for circulation in the Union 
within five years following that date and under the condition that full traceability is ensured 
by alternative means. For products  for which the applic ation of the Single European Code is 
not possible, e.g. because the products are stored under deep freeze conditions, the tissue 
establishments shall use the procedures applicab le to products with small labels as laid down 
in Article 10b paragraph 1(f).” 
 (5) The Annexes are amended in accordance with Annex I to this Directive. (6) A new Annex VIII is added, the text of which is set out in Annex II to this 
Directive." 
 
Article 2  
 
Member States shall bring into force the la ws, regulations and ad ministrative provisions 
necessary to comply with this Directive by […]
2 at the latest. They shall forthwith 
communicate to the Commission the text of those provisions. They shall apply the legislation 
from […]3 
When Member States adopt those provisions, they  shall contain a refere nce to this Directive 
or be accompanied by such a reference on the o ccasion of their official publication. Member 
States shall determine how such  reference is to be made. 
Member States shall communicate to the Commi ssion the text of the main provisions of 
national law which they adopt in th e field covered by this Directive. 
 
Article 3  
 
This Directive shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of  the European Union . 
                                                 
1 date of expiry of the transposition period 
2 18 months following entry into force of this Directive 
3 6 months after the transposition deadline.  
EN 10   EN Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 The President  […] 
  [Choose between the two options, depending on the person who signs.]    On behalf of the President  […] 
 [Position] 
 
  
EN 11   EN ANNEX I 
 
The Annexes to Directive 2006/86/EC are amended as follows: 
(1) Annex II, Part E, is amended as follows: 
(a) In point 1 the following point (g) is added: 
“(g) Single European Code as applicable to  the tissues and cells being distributed for 
human application or the donati on identification sequence as applicable to the tissues 
and cells released for circulation, other than distributed for human application”; 
(b) The second subparagraph of point 1 is replaced by the following: 
“If any of the information under points (d), (e) and (g) above cannot  be included on the 
primary container label, it must be provi ded on a separate sheet accompanying the 
primary container. This sheet must be pa ckaged with the primary container in a 
manner that ensures that they remain together.” 
(c) In  point 2, the following  point (j) is added: 
“(j) for imported tissues and cells, the country of procurement and the exporting 
country (if different from the procurement country)”. 
 
(a) Annexes III and IV are replaced by the following: 
 
‘Annex III  
NOTIFICATION OF SERI OUS ADVERSE REACTIONS  
PART A. Rapid notification for su spected serious adverse reactions 
Tissue establishment  
EU tissue establishment code (if applicable) 
Report identification  
Reporting date (year/month/day)  
Individual affected (recipient or donor)  
Date and place of procurement or  human application (year/month/day)  
Unique donation identification number 
Date of suspected serious adverse reaction (year/month/day)  
Type of tissues and cells involved in the suspected serious  adverse reaction 
Single European Code of tissues or cells involved in the suspected serious adverse 
reaction (if applicable) 
Type of suspected serious adverse reaction(s) 
PART B. Conclusions of Serious Adverse Reactions Investigation 
Tissue establishment  
EU tissue establishment code (if applicable) 
Report identification  
Confirmation date (year/month/day)  
Date of serious adverse reaction (year/month/day)   
EN 12   EN Unique donation identification number  
Confirmation of serious a dverse reaction (Yes/No) 
Single European Code of tissues or cells involved in the confirmed serious adverse 
reaction (if applicable) 
Change of type of serious adverse reaction (Yes/No) If YES, specify 
Clinical outcome (if known) 
- Complete recovery 
- Minor sequelae 
- Serious sequelae 
- Death 
Outcome of the investiga tion and final conclusions 
Recommendations for preventive and corrective actions” 
 
 
Annex IV   
NOTIFICATION OF SE RIOUS ADVERSE EVENTS  
PART A. Rapid notification for su spected serious adverse events 
Tissue establishment 
EU tissue establishment code (if applicable) 
Report identification 
Reporting date (year/month/day) 
Date of serious adverse event (year/month/day) 
Specification Serious adverse event, 
which may affect quality 
and safety of tissues and 
cells due to a deviation in: Tissues 
and cells defect Equipment 
failure Human 
error Other 
(specify) 
Procurement     
Testing     
Transport      
Processing      
Storage      
Distribution      
Materials      
Others (specify)      
PART B. Conclusions of Serious  Adverse Events  investigation 
Tissue establishment 
EU tissue establishment code (if applicable)  
Report identification 
Confirmation date (year/month/day) 
Date of serious adverse event (year/month/day)  
Root cause analysis (details) 
Corrective measures taken (details)’ 
 
4. Annexes VI and VII are replaced by the following:  
EN 13   EN  
‘Annex VI   
Minimum data to be kept in accordance with Article 9(2)  
A. BY TISSUE ESTABLISHMENTS  
(1) Donor identification (2) Donation identification that will include at least: - Identification of the procurement organisation (including  contact details) or the tissue 
establishment 
- Unique donation number  - Date of procurement - Place of procurement - Type of donation (e.g. single v multi-tissue; autologous v allogenic; living v deceased) 
(3) Product identification that  will include at least: 
- Identification of the tissue establishment - Type of tissue and cell/pr oduct (basic nomenclature) 
- Pool number (if applicable) - Split number (if applicable)  - Expiry date - Tissue/cell status (i.e. quarantined, suitable for use etc.) - Description and origin of the products, proc essing steps applied, ma terials and additives 
coming into contact with tissues and cells and ha ving an effect on their quality and/or safety. 
- Identification of the facili ty issuing the final label 
(4) Single European Code (if applicable) (5) Human application identificati on that will include at least: 
- Date of distribution/disposal - Identification of the clinician or end user/facility 
B. BY ORGANISATIONS RESPON SIBLE FOR HUMAN APPLICATION 
(1) Identification of the supplier tissue establishment 
(2) Identification of the clinician or end user/facility 
(3) Type of tissues and cells 
(4) Product identification 
(5) Identification of the recipient 
(6) Date of application 
(7) Single European Code (if applicable)” 
 
 Annex VII
  
EN 14   EN THE STRUCTURE OF THE SINGLE EUROPEAN CODE  
DONATION IDENTIFICATION 
SEQUENCE  PRODUCT IDENTIFICATION  
SEQUENCE  
EU TISSUE 
ESTABLISHMENT 
CODE PRODUCT CODE 
ISO 
country 
code Tissue 
establish-
ment 
number UNIQUE 
DONA-
TION 
NUMBER Product 
Coding 
System 
identifier Product 
number  SPLIT 
NUMBER EXPIRY 
DATE 
2 
alphabetic 
characters 6 
alpha-
numeric 
characters 13 
alpha-
numeric 
characters 1 alphabetic 
character 7 
alpha-
numeric 
characters 3 
alpha-
numeric 
characters 8 
numeric 
characters’ 
 
ANNEX II 
 ‘Annex VIII   
Data to be recorded in the EU Tissue Establishment Compendium  
A. Tissue establishment information 
1. Name of the tissue establishment 2. National or international c ode of tissue establishment 
3. Name of the organisation in which the tissu e establishment is located (if applicable) 
4. Address of the tissue establishment 5. Publishable contact details: func tional email address, phone and fax 
B. Details on the authorisation, accredita tion, designation, or license of the tissue 
establishment 
1. Name of the authorising, accrediting, designa ting or licensing competent authority or 
authorities 
2. Name of the national competent authority or authorities responsible for maintenance 
of the EU Tissue Establishment Compendium  
3. Name of the authorisation, accreditation, desi gnation or license holder (if applicable) 
4. Tissues and cells for which the authorisa tion, accreditation, designation or license was 
granted 
5. Activities actually carried out for which the au thorisation, accredit ation, designation or 
license was granted  
6. Status of the authorisation, accredita tion, designation or lic ense (authorised, 
suspended, revoked, in part or in fu ll, voluntary cessation of activities) 
7.  Details of any conditions and exemptions added to the authorisa tion (if applicable).’