G/SPS/N/EU/344  
 
11 September 2019  
(19-5840) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Food and feed pro ducts of animal and plant origin  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Regulation (EU) 2019/1381 of the European Parliament 
and the Council on the transparency and sustainability of the EU risk assessment in the  
food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) 
No 1831/2003, (EC) No 2065/2003, (EC ) No 1935/2004, (EC) No 1331/2008, (EC) 
No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC (Text with EEA relevance) . 
Language(s):  English, French and Spanish . Number of pages:  28 
https://members.wto.org/crnattachments/2019/SPS/EEC/19_4997_00_e.pdf  
https://members.wto.org/crnattachments/2019/SPS/EEC/19_4997_00_s.pdf  
https://members.wto.org/crnattachments/2019/SPS/EEC/19_4997_00_f.pdf  
6. Description of content:  This Regulation - amendment of the Regulation (EC) 178/2002 
laying down the general principles and requirements of food law, establishing the 
European Food Safety Authority (EFSA) and laying down procedures in matters of food 
safety ("General F ood Law") and eight other sectoral acts - intends to improve the 
transparency of the EU risk assessment process carried out by EFSA, strengthen the long -
term sustainability of EFSA and improve risk communication. Among others, the new 
Regulation will adapt  the existing EU food safety system as follows:  
− Proactive public disclosure/Confidentiality/Public consultations of submitted studies  
All scientific data, studies and other information supporting applications as well as other 
requests for a scientific outp ut by EFSA shall be made publicly available proactively, with 
the exception of duly justified confidential information, early on in the EU risk assessment 
process. To that effect, closed lists of clearly -defined information items for which 
confidentiality may be claimed under certain conditions, with the exception of safety 
relevant information, are set out in the General Food Law and in seven other sectoral acts. 
More specifically: When an applicant submits a request for authori sation accompanied by 
scient ific data, studies and other supporting information, it may request certain parts of 
the submitted data, studies and other information to be kept confidential. This request 
must be duly justified (proof of "potential harm to a significant degree" in case o f public 
disclosure). The applicant should submit a non -confidential version and a confidential 
version of the submitted data, studies and other information. Without delay and once an 
application is found valid or admissible, EFSA would make the non -confid ential version of 
those studies, as submitted by the applicant, public. In parallel, EFSA would assess the G/SPS/N/EU/344  
 
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  confidentiality claim within ten weeks. Once the assessment is completed, any additional 
data and information for which confidentiality requests ha ve been considered as unjustified 
would also be made public (final non -confidential version as assessed by EFSA). Upon 
receipt of the confidentiality decision by EFSA, applicants would have the right to make a 
confirmatory application asking EFSA to reconsid er its decision. Following public disclosure, 
EFSA will launch public consultations on the submitted data, studies and other information 
to ensure access to the widest evidence -base possible before it delivers its scientific 
output.  
The public disclosure of all information supporting applications or other requests for 
scientific output by EFSA shall be without prejudice to any existing rules concerning 
Intellectual Property Rights (which may set out limitations on certain uses of the disclosed 
documents on their content), and "data exclusivity rules ". The disclosure to the public shall 
not be considered as an explicit or implicit permission or licence for the relevant data and 
information and their content to be used. EFSA shall ensure  that clear undertakings or 
signed statements are given to that effect by those accessing the relevant documents, 
prior to their disclosure.  
− Notification of studies  
EFSA shall establish and manage a database of studies commissioned or carried out (at 
pre-submission phase) by business operators to support a future application or notification 
in relation to which Union law makes provisions for EFSA to provide a scientific output, 
including a scientific opinion. Business operators shall, without delay, notify EFSA of the 
title and the scope of the study, the laboratory or testing facility carrying out the study, 
and the starting and planned completion dates of any study commissioned or carried out 
by them to support an application or a notification. The notific ation obligation shall also 
apply to laboratories and other testing facilities located in the Union carrying out those 
studies, and also to laboratories and other testing facilities located in third countries 
insofar as set out in relevant agreements and a rrangements. Certain procedural 
consequences of non -compliance with the notification requirement are also foreseen, e.g. 
an application or notification shall not be considered valid or admissible where it is 
supported by studies that have not been notified , unless the applicant or notifier provides 
a valid justification for non -notification of such studies.  
− Fact-finding missions  
Within four years after the entry into application of the Regulation, Commission experts 
shall perform fact -finding missions in me mber States to assess the application by 
laboratories and other testing facilities of the relevant standards for carrying out tests and 
studies submitted to EFSA as part of an application, as well as the compliance with the 
notification obligation. Commiss ion experts shall also perform fact -finding missions to 
assess the application of relevant standards by laboratories and other testing facilities 
located in third countries insofar as set out in relevant agreements and arrangements. The 
Commission, EFSA an d the member States shall ensure the appropriate follow -up to these 
non-compliances. The outcome of the fact -finding missions shall be presented in an 
overview report, on which basis the Commission shall - if appropriate - submit a legislative 
proposal as regards any necessary control procedures, including audits.  
7. Objective and rationale: [X]  food safety, [X]  animal health, [X]  plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : Procedural Manual - Section IV - Working principles 
for risk analysis for application in the framework of the Codex Alimentarius  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  G/SPS/N/EU/344  
 
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  Does this p roposed regulation conform to the relevant international standard?  
[X] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:    
10. Proposed date of adoption (dd/mm/yy) : 13 June 2019  
Proposed date of publication (dd/mm/yy) : 6 September 2019  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : 20 days after publication in the Official Journal of the European Union.  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
available) of other body:   
European Commission  
DG Health and Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu  
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
European Commission  
DG Health and Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu