I 
(Legislativ e acts) 
REGUL ATIONS 
REGUL ATION (EU) 2019/1381 OF THE EUR OPEAN PARLIAMENT AND OF THE COUNCIL 
of 20 June 2019 
on the transparency and sust ainability 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 Directiv e 2001/18/EC 
(Text with EEA relevance) 
THE EUR OPEAN PARLIAMENT AND THE COUNCIL OF THE EUR OPEAN UNION, 
Having regar d to the Treaty on the Functioning of the European Union, and in particular Article 43(2), Article 114 
and Article 168(4)(b) thereof, 
Having regar d to the proposal from the European Commission, 
After transmission of the draf t legislative act to the national parliaments, 
Having regar d to the opinion of the European Economic and Social Committ ee (1), 
Having regar d to the opinion of the Committ ee of the Regions (2), 
Acting in accordance with the ordinar y legislative procedure (3), 
Whereas: 
(1)  Regulation (EC) No 178/2002 of the European Parliament and of the Council (4) lays down the general principles 
and requirements of food law, so as to form a common basis for measures govern ing food law at both Union 
and national level. It provides, inter alia, that food law is to be based on risk analysis, excep t where this is not 
appropr iate to the circumstances or the nature of the measure. 
(2)  Regulation (EC) No 178/2002 defines risk analysis as a process consisting of three interconnected components: 
risk assessment, risk management, and risk communication. For the purposes of risk assessment at Union level, it 
establishes the European Food Safe ty Author ity (the ‘Auth ority’), as the responsible Union risk assessment body in 
matt ers relating to food and feed safety . 
(3)  Risk communication is an essential part of the risk analysis process. The REFIT evaluation of the general food law 
(Regulation (EC) No 178/2002) of 2018 (‘Fitness Check of the General Food Law’) found that risk communication 
is not considered to be effective enough overall. This has an impact on consumers' conf idence in the outcome of 
the risk analysis process. 6.9.2019 L 231/1 Official Jour nal of the European Union EN     
(1)OJ C 440, 6.12.2018, p. 158. 
(2)OJ C 461, 21.12.2018, p. 225. 
(3)Position of the European Parliament of 17 Apr il 2019 (not yet published in the Offi cial Jour nal) and the decision of the Council of 
13 June 2019. 
(4)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and 
requirements of food law, establishing the European Food Safet y Authority and laying down procedures in matt ers of food safet y 
(OJ L 31, 1.2.2002, p. 1). (4)  It is necessar y, theref ore, to ensure transparent, continuous and inclusive risk communication throughout the risk 
analysis, involving Union and national risk assessors and risk manag ers. Such risk communication should 
strengthen citizens' trust that the risk analysis is under pinned by the objective of ensur ing a high level of 
prot ection of human health and consumers' inter ests. That risk communication should also be capable of 
contr ibuting to a participatory and open dialogue between all interest ed parties in order to ensure that the 
prevalence of the public interest, and accuracy , compreh ensiveness, transparency , consist ency and accountability 
are take n into account in the risk analysis process. 
(5)  Risk communication should place particular emphasis on explaining in an accurate , clear , comprehensive, 
coherent, appropr iate and timely manner not only risk assessment findings themselves but also how such 
findings are used to help inform risk manage ment decisions along with other legitimate factors, where relevant. 
Information should be provid ed on how risk manag ement decisions were reach ed and on the factors, other than 
the results of the risk assessment, whic h were considered by the risk managers, as well as how those factors were 
weighed up against each other . 
(6)  Given the ambiguity in the public percep tion of the differ ence between hazard and risk, risk communication 
should endeav our to clarify that distinction and thereby ensure that such distinction is better underst ood by the 
general public. 
(7)  Where there are reasonable grounds to suspect that a food or feed may present a risk for human or animal health 
due to non-com pliance resulting from intentional violations of applicable Union law perpetrated through 
fraudulent or deceptive practices, public author ities, identifying to the fullest extent possible the products 
concer ned and the risk that they may present, should inform the public according ly as soon as possible. 
(8)  It is necessar y to establish general objectives and principles of risk communication, taking into account the 
respective roles of risk assessors and managers, while guarant eeing their independence. 
(9)  On the basis of the general objectives and principles, a general plan on risk communication should be established 
in close cooperation with the Author ity and Member State s, and follo wing relevant public consultations. That 
general plan should promote an integrat ed risk communication framewor k for all risk assessors and risk 
manag ers at Union and national level on all matte rs relating to the food chain. It should also allow for the 
necessar y flexibility and should not deal with situations specifi cally covered by the general plan for crisis 
manag ement. 
(10)  The general plan on risk communication should identify the key factors to be taken into account when 
consider ing the type and level of risk communication activities needed, such as the different levels of risk, the 
nature of the risk and its poten tial impact on human health, animal health and, where relevant, the envi ronment, 
who and what are directly or indirectly affected by the risk, the levels of exposure to a hazard, the level of 
urgency and the ability to control risk, and other factors that influence risk percep tion, including the applicable 
legal framewor k and relevant market conte xt. 
(11)  The general plan on risk communication should also identify the tools and channels to be used and should 
establish appropr iate mechanisms of coordination and cooperation between the risk assessors and risk managers 
at Union and national level involved in the risk analysis process, in particular where several Union agencies 
provid e scientific outputs on the same or on related subject matt ers, to ensure coherent risk communication and 
an open dialogue amongst all interest ed parties. 
(12)  Transparency of the risk assessment process contr ibut es to greater legitimacy of the Author ity being acquired in 
the eyes of the consumers and general public in the pursuit of its mission, increases their conf idence in its work 
and ensures that the Author ity is more accountable to the Union citizens in a democratic system. It is theref ore 
essential to strengthen the confidence of the general public and other inter ested parties in the risk analysis 
under pinning the relevant Union law, and in particular in the risk assessment, including the transparency thereof 
as well as the organisation, functioning and independence of the Author ity. 
(13)  It is appropr iate to increase the role of Member States as well as the effort and engag ement of all parties involved 
in the Manag ement Board of the Author ity (the ‘Manag ement Board’). 6.9.2019 L 231/2 Official Jour nal of the European Union EN     (14)  Exper ience shows that the role of the Manage ment Board is focused on administrative and financial aspects and 
does not impa ct on the independence of the scientific work performe d by the Author ity. It is thus appropr iate to 
include representatives of all Member State s, of the European Parliament and of the Commission as well as of 
civil society and industr y organisations in the Management Board, while providin g that those representatives 
should have exper ience and exper tise not only in the fields of food chain law and policy , including risk 
assessment, but also in the fields of manag erial, administrative, financial and legal matt ers and ensur ing that they 
act independently in the public inter est. 
(15)  The members of the Manage ment Board should be select ed and appointed in such a way as to secure the highest 
standards of compet ence and the broadest range of relevant exper ience available. 
(16)  The Fitness Check of the General Food Law identified certain shor tcomings in the long-t erm capability of the 
Author ity to maintain its high-level exper tise. In particular , there has been a decrease in the number of candidates 
applying to be members of the Author ity's Scientific Panels. The system has thus to be strengthened and Member 
States should take a more active role to ensure that a suffi cient pool of exper ts is available to meet the needs of 
the Union risk assessment system in terms of high level of scientific exper tise, independence and multidisciplinar y 
exper tise. 
(17)  To preser ve the independence of the risk assessment from risk management and from other interests at Union 
level, it is appropr iate that the selection by the Author ity's Executive Director and the appointment by the 
Manage ment Board of the members of the Author ity's Scientific Committee and Scientific Panels be based on 
strict criteria ensur ing the excellence and independence of the exper ts while also ensur ing the required multidisci ­
plinar y exper tise for each Scientific Panel. It is essential to that end that the Executive Director , whose function is 
to defend the Author ity's interests and in particular the independence of its exper tise, have a role in the selection 
of those scientific exper ts. The Manage ment Board should endeav our to ensure, to the largest extent possible, that 
exper ts appointe d as members of the Scientifi c Panels are scientists who are also actively conducting research , 
and publishing their research findings in peer -reviewed scientifi c jour nals, provid ed that they comply with the 
strict criteria of excellence and independence. Proper financial compensation of the exper ts should be ensured. 
Further measures should also be put in place to ensure that scientifi c exper ts have the means to act indepen ­
dently . 
(18)  It is essential to ensure the efficient operation of the Author ity and to improve the sustainability of its exper tise. 
It is theref ore necessar y to strengthen the suppor t provided by the Author ity and the Member State s to the work 
of the Scientific Committ ee and the Scientific Panels. In particular , the Author ity should orga nise the preparatory 
work suppor ting the tasks of the Scientifi c Panels, including by requesting the Author ity's staff or national 
scientific organisations netw orking with the Author ity to draf t preparatory scientific opinions to be peer -reviewed 
and adop ted by those Scientific Panels. That should be without prejudice to the independence of the Author ity's 
scientific assessments. 
(19)  Author isation procedures are based on the principle that it is for the applicant or the notifier to prove that the 
subject matt er of an application or notification compl ies with Union requirements. That principle is based on the 
premise that human health, animal health and, where relevant, the environment are better prote cted where the 
burden of proof is on the applicant or the notifier since it has to prove that the subject matt er of its application 
or notification is safe prior to its placing on the mark et, instead of the public author ities having to prove that 
that subject matte r is unsafe in order to be able to ban it from the market. In accordance with that principle and 
the applicable regulator y requirements, in suppor t of applications or notifications under Union sector al law, 
applicants or notifiers are required to submit relevant studies, including tests, to demonstrate the safety and, in 
some cases, the efficacy of a subject matt er. 
(20)  Union law provides for the cont ent of applications and notificati ons. It is essential that the application or 
notification submitte d to the Author ity for its risk assessment meet the applicable specifi cations to ensure the 
best quality scientifi c assessment by the Authority. Applicants or notifi ers and in particular small and medium- 
sized enter prises do not alwa ys have a clear understanding of those specifi cations. It is thus appropr iate that, 
where the Auth ority may be request ed to provid e a scientific output, it should provid e advice to a potential 
applicant or notifier upon request, before an application or notification is formally submitted. Such pre- 
submission advice should relate to the rules applicable to, and the content required for, an application or 
notification and should not address the design of the studies to be submitted, as that remains the applicant's re­
sponsibility . 6.9.2019 L 231/3 Official Jour nal of the European Union EN     (21)  Where the Auth ority may be request ed to provide a scientifi c output, it should have knowle dge of all studies 
performed by an applicant with a view to suppor ting an application under Union law. To that end, it is necessar y 
and appropr iate that, when business operat ors commission or carry out studies with a view to submitting an 
application or notifi cation, they notify those studies to the Auth ority. The oblig ation to notify such studies 
should also apply to the laboratori es and other testing facilities carrying them out. Information about the notified 
studies should be made public only once a corresponding application has been made public in accordance with 
the applicable rules on transparency . In order to ensure effective implementation of that oblig ation, it is 
appropr iate to provide for certain procedural consequences in the event of non-com pliance. The Authority 
should, in that cont ext, lay down practical arrange ments to implement that oblig ation, including procedures for 
requesting and making public the justif ications for the non-compliance. 
(22)  In accordance with Directive 2010/63/EU of the European Parliament and of the Council (5), tests on animals 
should be replaced, reduced or refined. Theref ore, within the scope of this Regulation, duplication of animal 
testing should be avoided, where possible. 
(23)  In the case of applications or notifi cations to request the renewal of an author isation or an appro val, the 
author ised or appro ved substance or product has already been on the mark et for several years. Exper ience and 
kno wledge theref ore already exist with regar d to that substance or product. Where the Authority may be 
request ed to provid e a scientific output, it is appropr iate for studies planned for suppor ting requests for renewals, 
including information on the proposed design, that have been notifi ed by the applicant or the notifier to the 
Author ity, to be submitted for consultation of third parties. The Author ity should systematically provide advice 
to the applicants or to the notifier s on the cont ent of the intended renewal application or notific ations, as well as 
on the design of studies, taking into account the comments received. 
(24)  There are certain public concer ns about the Author ity's assessment in the area of author isation procedures being 
primar ily based on industr y studies. It is of utmost impor tance that the Author ity carry out searches in scientifi c 
literature to be able to consider other data and studies existing on the subject matt er submitted to its assessment. 
In order to provide an additional level of guarantee to ensure that the Author ity can have access to all relevant 
scientific data and studies available on a subject matte r of an application or a notifi cation for an author isation or 
a renewal of an author isation or an appro val, it is appropr iate to provi de for consultation of third parties in 
order to identify whether other relevant scientifi c data or studies are available. To increase the effectiveness of the 
consultation, the consultation should take place immediately after the studies submitted by industr y included in 
an application or a notification are made public, under the applicable transparency rules. Where there is a risk 
that the results of a public consultation cannot be given proper consideration because of the applicable deadlines, 
it is appropr iate to provide for a limited extension of those deadlines. 
(25)  Food safety is a sensitive matt er of prime interest for all Union citizens. While maintaining the principle that the 
burden to prove compliance with Union requirements is on the industr y, it is impor tant to establish an additional 
verification tool, namely the commissioning of additional studies with the objective of verifying evidence used in 
the cont ext of risk assessment to address specifi c cases of high societal impor tance where there are serious 
contro versies or conf licting results. Consider ing that those verification studies would be financed from the Union 
budget and that the use of this excep tional verification tool should remain propor tionate, the Commission, taking 
into account the views expressed by the European Parliament and by Member States, should be responsible for 
triggering the commissioning of such verification studies. Account should be take n of the fact that in some 
specific cases the verification studies commissioned may need to have a wider scope than the evidence at stake , 
for example, in cases where new scientific developments become available. 
(26)  The Fitness Check of the General Food Law demonstrated that, although the Author ity has made considerable 
progress in terms of transparency , the risk assessment process, especially in the conte xt of author isation 
procedures covering the food chain, is not alwa ys perceived as being fully transparent. That is also partly due to 
the diffe rent transparency and conf identiality rules that are laid down in Regulation (EC) No 178/2002 and in 
other Union sector al legislative acts. The interplay among those acts can have an impact on the acceptance of the 
risk assessment by the general public. 
(27)  The European citizens' initiative entitled ‘Ban glyphosate and protect people and the environment from toxic 
pesticides’ further conf irmed concer ns regarding transparency with respect to studies commissioned by the 
industr y and submitted in author isation procedures. 6.9.2019 L 231/4 Official Jour nal of the European Union EN     
(5)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for 
scientific purposes (OJ L 276, 20.10.2010, p. 33). (28)  It is theref ore necessar y to strengthen the transparency of the risk assessment in a proactive manner . All scientifi c 
data and information suppor ting requests for author isations or for approvals under Union law as well as other 
requests for scientific output should be made publicly available in a proactive manner and be easily accessible as 
early as possible in the risk assessment process. However , such disclosure to the public should be without 
prejudice to any rules concer ning intellectual proper ty rights or to any provisions of Union law protecting the 
investment made by innovat ors in gathering the information and data suppor ting relevant applications or notifi ­
cations. It should be ensured that such disclosure to the public is not considered to be permission for further 
uses or exploitation, without jeopardising the proactive character of disclosure to the public and the easy public 
access to the disclosed data and information. 
(29)  To ensure the transparency of the risk assessment, a summar y of the pre-submission advice should be made 
public only once a corresponding application or notifi cation has been made public in accordance with the 
applicable rules on transparency . 
(30)  Where the opinion of the Auth ority is requested in relation to applications or notifications submitted under 
Union law, and having regard to its obligation to ensure public access to all suppor ting information with respect 
to the provision of its scientifi c outputs, the Author ity should have responsibility for assessing confidentiality 
requests. 
(31)  To determine what level of proactive disclosure to the public strikes the appropr iate balance, the relevant rights 
of the public to transparency in the risk assessment process should be weighed up against the rights of applicants 
or notifier s, taking into account the objectives of Regulation (EC) No 178/2002. 
(32)  With respect to the application or notification procedures provided for in Union law, exper ience gained so far 
has shown that certain items of information are generally considered sensitive and should remain confidential 
across the differ ent sectoral procedures. It is theref ore appropr iate to lay down in Regulation (EC) No 178/2002 
a horizontal list of items of information whose disclosure, as demonstrated by the applicant or the notifier , will 
poten tially harm the commercial inter ests concer ned to a signif icant degree and whic h should not theref ore be 
disclosed to the public. Those items should include the manufactur ing and production process, including the 
method and innovati ve aspects thereof, as well as technical and industr ial specifi cations, such as impur ities, 
inherent to that process other than information which is relevant to the assessment of safety . Only in very limit ed 
and excep tional circumstances relating to foreseeable health effects or, where an environmental assessment is 
required under Union sectoral law, to environmental effects, or where relevant author ities have identified urgent 
needs to prote ct human health, animal health or the environment, should such information be disclosed. 
(33)  For the purposes of clarity and to increase legal certainty , it is necessar y to set out the specifi c procedural 
requirements to be followe d by an applicant or by a notifi er in respect of a request for information submitted to 
suppor t an application or a notifi cation under Union law to be treated in a conf idential manner . 
(34)  It is also necessar y to set out specifi c requirements with respect to the prot ection and conf identiality of personal 
data for the purposes of the transparency of the risk assessment process, taking into account Regulations (EU) 
2018/1725 (6) and (EU) 2016/679 (7) of the European Parliament and of the Council. According ly, no personal 
data should be made publicly available under this Regulation, unless it is necessar y and propor tionate for the 
purposes of ensur ing the transparency , independence and the reliability of the risk assessment process, while 
preventing conf licts of interests. In particular , for the purpose of ensur ing the transparency and to avoid conf licts 
of interest, it is necessar y to publish the names of the participants and obser vers in certain meetings of the 
Author ity. 
(35)  For the purpose of increased transparency and in order to ensure that requests for scientific outputs received by 
the Authority are processed in an effective manner , standard data formats should be developed. 6.9.2019 L 231/5 Official Jour nal of the European Union EN     
(6)Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the prot ection of natural persons 
with regar d to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such 
data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). 
(7)Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 Apr il 2016 on the prot ection of natural persons with 
regar d to the processing of personal data and on the free mov ement of such data, and repealing Directive 95/46/EC (General Data 
Prot ection Regulation) (OJ L 119, 4.5.2016, p. 1). (36)  Having regar d to the fact that the Author ity would be required to store scientific data, including confidential and 
personal data, it is necessar y to ensure that such stora ge is carried out in accordance with a high level of secur ity. 
(37)  Further more, in order to assess the effectiveness and efficiency of the differ ent legal provisions applicable to the 
Author ity, it is also appropr iate to provid e for a Commission evaluation of the Authority. That evaluation should, 
in particular , review the procedures for selecting the members of Scientific Committ ee and Scientific Panels, for 
their degree of transparency , cost-effe ctiveness, and suitability to ensure independence and compet ence, and to 
prevent conf licts of interests. 
(38) Studies, including tests, submitte d by business operat ors in suppor t of applications usually compl y with internat ­
ionally recognised principles, whic h provid e a unif orm basis for their quality in particular in term s of reproduci ­
bility of results. However , issues of compl iance with the applicable standards, such as those set by Directive 
2004/10/EC of the European Parliament and of the Council (8) or those developed by the International 
Org anization for Standardization, may arise in some cases and this is why intern ational and national systems are 
in place to verify such compl iance. It is theref ore appropr iate for the Commission to carry out fact-finding 
missions to assess the application by laboratories and other testing facilities of the relevant standards for carrying 
out tests and studies submitted to the Author ity as part of an application. Those fact-fi nding missions would 
allow the Commission to identify , and to aim at correcting, possible weaknesses in the syste ms and non- 
compl iance and to provid e an additional level of guarant ees to reassure the general public on the quality of 
studies. Based on the conclusions of such fact-fi nding missions, the Commission could propose appropr iate 
legislative measures aimed at improving compl iance with the relevant standards. 
(39)  In order to ensure consistency with the proposed adaptations in Regulation (EC) No 178/2002, provisions 
relating to public access and the prot ection of conf idential information in Regulations (EC) No 1829/2003 (9), 
(EC) No 1831/2003 (10), (EC) No 2065/2003 (11), (EC) No 1935/2004 (12), (EC) No 1331/2008 (13), (EC) 
No 1107/2009 (14), (EU) 2015/2283 (15) and in Directive 2001/18/EC (16) of the European Parliament and of the 
Council should be amended. 
(40)  To ensure that sector al specifi cities with respect to conf idential information are take n into account, it is necessar y 
to weigh up the relevant rights of the public to transparency in the risk assessment process against the rights of 
applicants or of notifi ers, taking into account the specific objectives of sector al Union law as well as exper ience 
gained. According ly, it is necessar y to make specific amendments to Regulations (EC) No 1829/2003, (EC) 
No 1831/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 
2001/18/EC in order to provide for additional confidential items to those set out in Regulation (EC) 
No 178/2002. 6.9.2019 L 231/6 Official Jour nal of the European Union EN     
(8)Directive 2004/10/EC of the European Parliament and of the Council of 11 Febr uary 2004 on the harmonisation of laws, regulations 
and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their 
applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44). 
(9)Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 Sept ember 2003 on genetically modified food and 
feed (OJ L 268, 18.10.2003, p. 1). 
(10)Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 Sept ember 2003 on additives for use in animal 
nutr ition (OJ L 268, 18.10.2003, p. 29). 
(11)Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smok e flavourings used or 
inten ded for use in or on foods (OJ L 309, 26.11.2003, p. 1). 
(12)Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 Octo ber 2004 on mat erials and articles intended 
to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4). 
(13)Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common author is­
ation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1). 
(14)Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concer ning the placing of plant 
prot ection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). 
(15)Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending 
Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the 
European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1). 
(16)Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment 
of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1). (41)  The rights on access to documents enshr ined in Regulation (EC) No 1049/2001 of the European Parliament and 
of the Council (17) and, where environmental information is concer ned, the rights enshr ined in Regulation (EC) 
No 1367/2006 (18) and Directive 2003/4/EC (19) of the European Parliament and of the Council are unaffect ed by 
this Regulation. The rights provided by those acts should not in any manner be limited by the provis ions on 
proactive dissemination laid down in this Regulation and the relevant assessment of conf identiality request. 
(42)  In order to ensure unif orm conditions for the implementation of Regulation (EC) No 178/2002 with rega rd to 
the adop tion of a general plan for risk communication and the adop tion of standard data formats, implemen ting 
powers should be conferred on the Commission. Those powers should be exer cised in accordance with 
Regulation (EU) No 182/2011 of the European Parliament and of the Council (20). 
(43)  In order to enable the Commission, Member States, the Author ity and the business operat ors to adapt to the new 
requirements set by this Regulation while ensur ing that the Author ity continues its smooth operation, it is 
necessar y to provide for transitional measures for the application of this Regulation. 
(44)  Since the appointment of the members of the Scientifi c Committ ee and Scientific Panels depends on the entr y in 
function of the new Management Board, it is necessar y to provid e for specifi c transitional provisions allowing 
a prolongation of the current term of office of the members of the Scientific Committ ee and Scientifi c Panels. 
(45)  The European Data Protection Super visor was consulted in accordance with Article 28(2) of Regulation (EC) 
No 45/2001 of the European Parliament and of the Council (21), 
HAVE ADOPTED THIS REGUL ATION: 
Article 1 
Amendments to Regulation (EC) No 178/2002 
Regulation (EC) No 178/2002 is amended as follows:  
(1) in Article 6, the following paragraph is added: 
‘4. Risk communication shall fulfil the objectives and respect the general principles set out in Articles 8a 
and 8b.’;  
(2) in Chapt er II, the followi ng Section is inser ted: 
‘Section 1a 
Risk communication 
Article 8a 
Objectiv es of risk communication 
Taking into account the respective roles of risk assessors and risk manag ers, risk communication shall pursue the 
following objectives: 
(a)  raise aware ness and understanding of the specific issues under consideration, including in cases of diverge nces 
in scientifi c assessment, during the entire risk analysis process; 
(b)  ensure consiste ncy, transparency and clarity in formulating risk management recommendations and decisions; 6.9.2019 L 231/7 Official Jour nal of the European Union EN     
(17)Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European 
Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). 
(18)Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the 
provi sions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in En­
vironmental Matter s to Community institutions and bodies (OJ L 264, 25.9.2006, p. 13). 
(19)Directive 2003/4/EC of the European Parliament and of the Council of 28 Januar y 2003 on public access to environmental information 
and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26). 
(20)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general 
principles concer ning mechanisms for control by Member States of the Commission's exercise of impl ementing powers (OJ L 55, 
28.2.2011, p. 13). 
(21)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the prot ection of individuals with 
regar d to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 
12.1.2001, p. 1). (c)  provi de a sound basis, including, where appropr iate, a scientifi c basis, for understanding risk manag ement 
decisions; 
(d)  improve the overall effectiveness and efficiency of the risk analysis; 
(e)  foster public understanding of the risk analysis, including of the respective tasks and responsibilities of risk 
assessors and risk manag ers to enhance conf idence in its outcome; 
(f)  ensure appropr iate involvement of consumers, feed and food businesses, the academic community and all other 
interested parties; 
(g)  ensure appropr iate and transparent exchange of information with interested parties in relation to risks 
associated with the food chain; 
(h)  ensure the provision of information to consumers about risk prevention strateg ies; and 
(i)  contr ibute to the fight against the dissemination of false information and the sources thereof. 
Article 8b 
General principles of risk communication 
Taking into account the respective roles of risk assessors and risk manage rs, risk communication shall: 
(a)  ensure that accurat e and all appropr iate information is exchange d in an inter active and timely manner with all 
inter ested parties, based on the principles of transparency , openness, and responsiveness; 
(b)  provid e transparent information at each stage of the risk analysis process from the framing of requests for 
scientific advice to the provision of risk assessment and the adopt ion of risk manag ement decisions, including 
information on how risk management decisions were reac hed and whic h factors were considered; 
(c)  take into account risk perceptions of all interest ed parties; 
(d)  facilitate understanding and dialogue amongst all interest ed parties; and 
(e)  be clear and accessible, including to those not directly involved in the process or not having a scientific 
backg round, while duly respecting the applicable legal provisions on conf identiality and prot ection of personal 
data. 
Article 8c 
General plan for risk communication 
1. The Commission shall adopt, by means of imp lementing acts, a general plan for risk communication in order 
to achieve the objectives set out in Article 8a, in accordance with the general principles set out in Article 8b. The 
Commission shall keep that general plan update d, taking into account technical and scientific progress and 
exper ience gained. Those implementing acts shall be adopt ed in accordance with the procedure refer red to in 
Article 58(2). When prepar ing those implementing acts, the Commission shall consult the Auth ority. 
2. The general plan for risk communication shall promote an integrat ed risk communication framework to be 
followed both by the risk assessors and the risk managers in a coherent and systemat ic manner both at Union and 
national level. It shall: 
(a)  identify the key factors that need to be taken into account when consider ing the type and level of risk 
communication activities needed; 
(b)  identify the different types and levels of risk communication activities, and the appropr iate main tools and 
channels to be used for risk communication purposes, taking into account the needs of relevant target audience 
groups; 
(c)  establish appropr iate mechanisms of coordination and cooperation in order to strengthen coherence of risk 
communication amongst risk assessors and risk managers; and 
(d)  establish appropr iate mechanisms to ensure an open dialogue amongst consumers, food and feed businesses, 
the academic community and all other inter ested parties, and their appropr iate involvement.’; 6.9.2019 L 231/8 Official Jour nal of the European Union EN     (3) in Article 22(7), the second subparagraph is replaced by the following: 
‘It shall act in close cooperation with the compet ent bodies in the Member States that carry out similar tasks to 
those of the Author ity and, where appropr iate, with the relevant Union agencies.’;  
(4) Article 25 is amended as follows: 
(a)  paragraph 1 is replaced by the following: 
‘1. Each Member State shall nominate a member and an alternate member as its representatives to the 
Manage ment Board. The members and alternate members thus nominated shall be appointe d by the Council 
and have the right to vote.’; 
(b)  the follo wing paragraphs are inser ted: 
‘1a. In addition to members and alternate members referred to in paragraph 1, the Manage ment Board shall 
include: 
(a)  two members and two altern ate members appointed by the Commission as its representatives, with the 
right to vote; 
(b)  two members appointed by the European Parliament, with the right to vote; 
(c)  four members and four alternate members with the right to vote as representatives of civil society and food 
chain inter ests, namely one member and one alternate member from consumer organisations, one member 
and one alternate member from environmental non-gov ernmental organisations, one member and one 
alternate member from farmers organisations, and one member and one altern ate member from industr y 
organisations. 
The members and altern ate members referred to in point (c) of the first subparagraph shall be appointed by 
the Council in consultation with the European Parliament on the basis of a list whic h shall be drawn up by 
the Commission and sent to the Council. The list shall include more names than there are posts to be filled. 
The list drawn up by the Commission shall be forwarded to the European Parliament by the Council, 
together with the relevant backg round documents. As quickly as possible and at the latest within three 
months of the receip t of that list, the European Parliament may submit its views for consideration to the 
Council which shall then appoint those members. 
1b. The members and the altern ate members of the Management Board shall be nominated and appointe d 
on the basis of their relevant exper ience and exper tise in the field of food chain law and policy , including risk 
assessment, whilst ensur ing that there is relevant exper tise in the fields of manager ial, administrative, financia l 
and legal matte rs within the Management Board.’; 
(c)  paragraph 2 is replaced by the following: 
‘2. The term of office of members and altern ate members shall be four years and may be renewed. However , 
the term of office of the members and altern ate members referred to in point (c) of the first subparagraph of 
paragraph 1a may be renewed only once.’; 
(d)  in paragraph 5, the second subparagraph is replaced by the followi ng: 
‘Unless other wise provided, the Management Board shall act by a majority of its members. Alte rnate members 
shall represent the members in their absence and vote on their behalf.’;  
(5) Article 28 is amended as follows: 
(a)  paragraph 5 is replaced by the following: 
‘5. The members of the Scientific Committee who are not members of the Scientifi c Panels and the 
members of the Scientific Panels shall be appoint ed by the Management Board, acting upon a proposal from 
the Executive Direct or, for a five-year term of office, which may be renewed, following publication of a call for 
expression of interest in the Official Journal of the European Union, in relevant leading scientific publications and 
on the Authority's website. The Author ity shall publish such a call for expression of inter est after having 
informed the Member States about the necessar y criteria and fields of exper tise. 
The Member State s shall: 
(a)  publish the call for expression of inter est on the websites of their compet ent author ities and of their 
compet ent bodies which under take task s similar to those of the Author ity; 
(b)  inform relevant scientific organisations locat ed on their territory ; 6.9.2019 L 231/9 Official Jour nal of the European Union EN     (c)  encourage poten tial candidate s to apply ; and 
(d)  take any other appropr iate measures to suppor t the call for expression of interest.’; 
(b)  the follo wing paragraphs are inser ted: 
‘5a. The members of the Scientifi c Committee who are not members of Scientific Panels and the members 
of the Scientific Panels shall be selecte d and appointed in accordance with the following procedure: 
(a)  on the basis of the applications received to a call for expression of interest, the Executive Direct or shall 
draw up a draf t list of suitable candidates including at least twice the number of candidates necessar y to fill 
the posts in the Scientifi c Committee and the Scientific Panels and send the draf t list to the Management 
Board, indicating the specific multidisciplinar y exper tise needed in each Scientifi c Panel; 
(b)  on the basis of that draf t list, the Management Board shall appoint the members of the Scientific 
Committ ee who are not members of the Scientifi c Panels and the members of the Scientific Panels and 
draw up the reser ve list of candidates for the scientific Committ ee and the Scientifi c Panels; 
(c)  the selection procedure and the appointments of the members of the Scientific Committee who are not 
members of the Scientifi c Panels and the members of the Scientific Panels shall be made on the basis of the 
followi ng criteria: 
(i)  a high level of scientific exper tise; 
(ii)  independence and absence of conf lict of interests in accordance with Article 37(2) and the Author ity's 
independence policy and implementation of that policy in respect of the members of the Scientific 
Panels; 
(iii)  meeting the needs for the specifi c multi-disciplinar y exper tise of the Scientific Panel to which they will 
be appointed and the applicable language regime; 
(d)  where candidates have equivalent scientific exper tise, the Manage ment Board shall ensure that the broadest 
possible geographical distr ibution is achieved in the appointments. 
5b. When the Author ity identif ies that specifi c exper tise is missing in one or several Scientifi c Panels, the 
Executive Direct or shall propose to the Managem ent Board, in accordance with the procedure laid down in 
paragraphs 5 and 5a, the appointment of additional members of the relevant Scientific Panels. 
5c. The Manage ment Board shall adopt, on the basis of a proposal of the Executive Direct or, rules on the 
detailed organisation and timing of the procedures set up in paragraphs 5a and 5b. 
5d. Member State s and emplo yers of the members of the Scientific Committ ee and of the Scientific Panels 
shall refrain from giving those members, or the extern al exper ts participating in the working groups of the 
Scientific Committee or the Scientific Panels, any instr uction which is incompat ible with the individual tasks of 
those members and exper ts, or with the tasks, responsibilities and independence of the Author ity. 
5e. The Author ity shall suppor t the tasks of the Scientifi c Committ ee and Scientific Panels by organising 
their work, in particular the preparat ory work to be under taken by the Auth ority's staff or by designate d 
national scientific organisations refer red to in Article 36, including by organising the possibility for prepar ing 
scientific opinions to be peer -reviewed by the Scientifi c Panels before they adopt them. 
5f. Each Scientific Panel shall include a maximum of 21 members. 
5g. Members of Scientific Panels shall have access to comprehensive training on the risk assessment.’; 
(c)  in paragraph 9, point (b) is replaced by the follo wing: 
‘(b)  the number of members in each Scientific Panel but no more than the maximum number provided for in 
paragraph 5f.’; 6.9.2019 L 231/10 Official Jour nal of the European Union EN     (6) the follo wing Articles are inser ted: 
‘Article 32a 
Pre-submission advice 
1. Where Union law contains provisions for the Author ity to provide a scientifi c output, including a scientifi c 
opinion, the staff of the Auth ority shall, at the request of a poten tial applicant or notifier , provi de advice on the 
rules applicable to, and the cont ent required for, the application or notific ation, prior to its submission. Such 
advice provided by the staff of the Author ity shall be without prejudice and non-committal as to any subsequent 
assessment of applications or notific ations by the Scientifi c Panels. The staff of the Author ity providing the advice 
shall not be involved in any preparat ory scientifi c or technical work that is directly or indirectly relevant to the 
application or notification that is the subject of the advice. 
2. The Author ity shall publish general guidance on its website regar ding the rules applicable to, and the conte nt 
required for, applications and notificati ons, including, where appropr iate, general guidance on the design of 
required studies. 
Article 32b 
Notif ication of studies 
1. The Authority shall establish and manag e a database of studies commissioned or carried out by business 
operat ors to suppor t an application or notific ation in relation to whic h Union law contains provisions for the 
Author ity to provide a scientifi c output, including a scientifi c opinion. 
2. For the purposes of paragraph 1, business operat ors shall, without dela y, notify the Author ity of the title and 
the scope of any study commissioned or carried out by them to suppor t an application or a notification, as well as 
the laborat ory or testing facility carrying out that study , and its starting and planned compl etion dates. 
3. For the purposes of paragraph 1, laboratori es and other testin g facilities located in the Union shall also, 
without dela y, notify the Auth ority of the title and the scope of any study commissioned by business operat ors and 
carried out by such laborat ories or other testing facilities to suppor t an application or a notificati on, its starting 
and planned completion date s, as well as the name of the business operat or who commissioned such a study . 
This paragraph shall also apply , mutatis mutandis, to laboratories and other testing facilities located in third 
countr ies insof ar as set out in relevant agreements and arrange ments with those third countr ies, including as 
referred to in Article 49. 
4. An application or notifi cation shall not be considered valid or admissible where it is suppor ted by studies 
that have not been previously notified in accordance with paragraph 2 or 3, unless the applicant or notifier 
provi des a valid justification for the non-notification of such studies. 
Where studies have not been previously notifi ed in accordance with paragraph 2 or 3, and where a valid justifi ­
cation has not been provided, an application or notifi cation may be re-submitt ed, provid ed that the applicant or 
notifier notifies to the Auth ority those studies, in particular their title and their scope, the laboratory or testing 
facility carrying them out as well as their starting and planned compl etion dates. 
The assessment of the validity or the admissibility of such re-submitted application or notifi cation shall commence 
six months after the notification of the studies pursuant to the second subparagraph. 
5. An application or notifi cation shall not be considered valid or admissible, where studies that have previously 
been notified in accordance with paragraph 2 or 3 are not included in the application or notificati on, unless the 
applicant or notifi er provides a valid justif ication for the non-inclusion of such studies. 
Where the studies which have previously been notifi ed in accordance with paragraph 2 or 3 were not included in 
the application or notifi cation, and where a valid justif ication has not been provi ded, an application or notification 
may be resubmitt ed, provided that the applicant or notifier submits all the studies that were notified in accordance 
with paragraph 2 or 3. 
The assessment of the validity or admissibility of such re-submitt ed application or notificati on shall commence six 
months after the submission of the studies pursuant to the second subparagraph. 6.9.2019 L 231/11 Official Jour nal of the European Union EN     6. Where the Author ity detec ts, during its risk assessment, that studies notified in accordance with paragraph 2 
or 3 are not included in the corresponding application or notifi cation in full, and in the absence of a valid justifi ­
cation of the applicant or notifier to that effect, the applicable time limits within whic h the Author ity is required to 
deliver its scientific output shall be suspended. That suspension shall end six months after the submission of all 
data of those studies. 
7. The Auth ority shall mak e public the notifi ed information only in cases where it received a corresponding 
application or notifi cation and after the Author ity has decided on the disclosure of the accompan ying studies in 
accordance with Articles 38 to 39e. 
8. The Auth ority shall lay down the practical arrang ements for implementing the provisions of this Article, 
including arrange ments for requesting and making public the valid justifications in the cases refer red to in 
paragraphs 4, 5 and 6. Those arrang ements shall be in accordance with this Regulation and other relevant Union 
law. 
Article 32c 
Consultation of third parties 
1. Where the relevant Union law provides that an appro val or an author isation, including by means of 
a notification, may be renewed, the pote ntial applicant or notifier for the renewal shall notify the Author ity of the 
studies it intends to perform for that purpose, including information on how the various studies are to be carried 
out to ensure compl iance with regulatory requirements. Following such notifi cation of studies, the Author ity shall 
launc h a consultation of stakeholders and the public on the intended studies for renewal, including on the 
proposed design of studies. Taking into account the received comments from the stakeholders and the public 
whic h are relevant for the risk assessment of the intended renewal, the Authority shall provi de advice on the 
cont ent of the intended renewal application or notifi cation, as well as on the design of the studies. The advice 
provi ded by the Author ity shall be without prejudice and non-committal as to the subsequent assessment of the 
applications or notifications for renewal by the Scientific Panels. 
2. The Author ity shall consult stakeho lders and the public on the basis of the non-confi dential version of the 
application or notifi cation made public by the Author ity in accordance with Articles 38 to 39e, and immediate ly 
after such disclosure to the public, in order to identify whether other relevant scientifi c data or studies are available 
on the subject matte r concer ned by the application or notificati on. In duly justified cases, where there is a risk that 
the results of the public consultation performe d in accordance with this paragraph cannot be given proper con­
sideration because of the applicable time limits within which the Author ity is required to deliver its scientific 
output, those time limits may be extende d for a maximum period of seven weeks. This paragraph is without 
prejudice to the Auth ority's oblig ations under Article 33 and does not apply to the submission of any supple ­
mentar y information by the applicants or notifi ers during the risk assessment process. 
3. The Author ity shall lay down the practical arrang ements for implementing the procedures refer red to in this 
Article and Article 32a. 
Article 32d 
Verification studies 
Without prejudice to the oblig ation on applicants to demonstrat e the safety of a subject matter submitted to 
a system of author isation, the Commission, in excep tional circumstances of serious contro versies or conf licting 
results, may request the Author ity to commission scientifi c studies with the objective of verifying evidence used in 
its risk assessment process. The studies commissioned may have a wider scope than the evidence subject to 
verification.’;  
(7) Article 38 is amended as follows: 
(a)  paragraph 1 is replaced by the following: 
‘1. The Author ity shall carry out its activities with a high level of transparency . It shall in particular make 
public: 
(a)  agendas, participant lists and minute s of the Manage ment Board, the Advisor y Forum, the Scientifi c 
Committ ee and the Scientifi c Panels and their working groups; 
(b)  all its scientific outputs, including the opinions of the Scientifi c Committee and the Scientific Panels after 
adoptio n, minor ity opinions and results of consultations performed during the risk assessment process 
alwa ys being included; 6.9.2019 L 231/12 Official Jour nal of the European Union EN     (c)  scientific data, studies and other information suppor ting applications, including supplementar y information 
supplied by applicants, as well as other scientific data and information suppor ting requests from the 
European Parliament, the Commission and the Member States for a scientific output, including a scientifi c 
opinion, taking into account the prote ction of conf idential information and the protection of personal data 
in accordance with Articles 39 to 39e; 
(d)  the information on which its scientific outputs, including scientific opinions are based, taking into account 
the protection of conf idential information and the prot ection of personal data in accordance with 
Articles 39 to 39e; 
(e)  the annual declarations of interest made by the members of the Managem ent Board, the Executive Direct or 
and the members of the Advisory Forum, the Scientific Committ ee and the Scientific Panels, as well as the 
members of the working groups, and the declarations of inter est made in relation to items on the agendas 
of meetings; 
(f)  its scientific studies in accordance with Articles 32 and 32d; 
(g)  the annual repor t of its activities; 
(h)  requests from the European Parliament, from the Commission or from a Member State for scientific 
opinions which have been refused or modified and the justif ications for the refusal or modification; 
(i)  a summar y of the advice provid ed to poten tial applicants at pre-submission phase pursuant to Articles 32a 
and 32c. 
Information refer red to in the first subparagraph shall be made public without dela y, with the exce ption of the 
information referred to in point (c) thereof, as far as applications are concer ned, and in point (i) thereof, which 
shall be made public without dela y once an application has been considered valid or admissible. 
The information refer red to in the second subparagraph shall be made public in a dedicat ed section of the 
Author ity's website. That dedicat ed section shall be publicly available and easily accessible. That information 
shall be available to be down loaded, printed and searc hed through in an electronic format.’; 
(b)  the follo wing paragraph is inser ted: 
‘1a. The disclosure of the information refer red to in points (c), (d) and (i) of the first subparagraph of 
paragraph 1 to the public shall be without prejudice to: 
(a)  any existing rules concer ning intellectual proper ty rights which set out limitations on certain uses of the 
disclosed documents or their cont ent; and 
(b)  any provisions set out in Union law prote cting the inve stment made by innovat ors in gather ing the 
information and data suppor ting relevant applications for author isations (“data exclusivity rules”). 
The disclosure to the public of the information refer red to in point (c) of the first subparagraph of paragraph 1 
shall not be considered to be explicit or implicit permission or licence for the relevant data and information 
and their cont ent to be used, reproduced, or other wise exploit ed in breac h of any intellectual proper ty right or 
data exclusivity rules, and the Union shall not be responsible for its use by third parties. The Author ity shall 
ensure that clear under takings or signed statements are given to that effect by those who access the relevant 
information prior to its disclosure.’; 
(c)  paragraph 3 is replaced by the following: 
‘3. The Author ity shall lay down the practical arrange ments for implementing the transparency rules 
referred to in paragraphs 1, 1a and 2 of this Article, taking into account Articles 39 to 39g and 41.’;  
(8) Article 39 is replaced by the followi ng: 
‘Article 39 
Conf identiality 
1. By way of derogation from Article 38, the Author ity shall not make public any information for whic h 
confidential treatment has been requeste d under the conditions laid down in this Article. 6.9.2019 L 231/13 Official Jour nal of the European Union EN     2. Upon the request of an applicant, the Authority may grant confidential treatment only with respect to the 
following items of information where the disclosure of such information is demonstrat ed by the applicant to 
poten tially harm its inter ests to a signif icant degree: 
(a)  the manufactur ing or production process, including the method and innovative aspects thereof, as well as other 
technical and industr ial specifi cations inherent to that process or method, excep t for information which is 
relevant to the assessment of safety ; 
(b)  commercial link s between a producer or importer and the applicant or the author isation holder , where 
applicable; 
(c)  commercial information revealing sourcing, mark et shares or business strategy of the applicant ; and 
(d)  quantitative composition of the subject matte r of the request, excep t for information whic h is relevant to the 
assessment of safety . 
3. The list of information referred to in paragraph 2 shall be without prejudice to any sectoral Union law. 
4. Notwithstanding paragraphs 2 and 3: 
(a)  where urgent action is essential to protect human health, animal health or the environment, such as in 
emerg ency situations, the Auth ority may disclose the information refer red to in paragraphs 2 and 3; 
(b)  information which forms part of conclusions of scientific outputs, including scientific opinions, delivered by 
the Author ity and whic h relate to foreseeable effects on human health, animal health or the environment, shall 
never theless be made public.’;  
(9) the follo wing Articles are inser ted: 
‘Article 39a 
Conf identiality request 
1. When submitting an application, suppor ting scientifi c data and other supplementar y information in 
accordance with Union law, the applicant may request certain parts of the information submitte d to be treated as 
confidential in accordance with Article 39(2) and (3). Such request shall be accompan ied by verifiable justification 
that demonstrate s how making public the information concer ned signif icantly harms the interests concer ned in 
accordance with Article 39(2) and (3). 
2. Where an applicant submits a confidentiality request, it shall provi de a non-confide ntial version and 
a conf idential version of the information submitted in accordance with standard data formats, where they exist, 
pursuant to Article 39f. The non-confidential version shall not include the information the applicant deems 
confidential on the basis of Article 39(2) and (3) and shall indicate the places where such information has been 
delet ed. The conf idential version shall contain all information submitted, including information the applicant 
deems conf idential. Information request ed to be treated as confidential in the conf idential version shall be clearly 
mark ed. The applicant shall clearly indicate the grounds on the basis of whic h conf identiality is requeste d for the 
diffe rent pieces of information. 
Article 39b 
Decision on conf identiality 
1. The Auth ority shall: 
(a)  make public the non-confide ntial version of the application as submitted by the applicant without dela y once 
that application has been considered valid or admissible; 
(b)  proceed, without dela y, to a concrete and individual examination of the confidentiality request in accordance 
with this Article; 
(c)  inform the applicant in writing of its intention to disclose information and the reasons for that, before the 
Author ity formally take s a decision on the conf identiality request. If the applicant disagrees with the 
assessment of the Author ity, the applicant may state its views or withdraw its application within two weeks of 
the date on whic h it was notifi ed of the Author ity's position; 
(d)  adopt a reasoned decision on the confidentiality request, taking into account the obser vations of the applicant, 
within 10 weeks of the date of receipt of the conf identiality request with respect to applications and without 
dela y in the case of supplementar y data and information; notify the applicant of its decision and provide 
information on the right to submit a conf irmatory application in accordance with paragraph 2; and inform the 
Commission and the Member States, where appropr iate, of its decision; and 6.9.2019 L 231/14 Official Jour nal of the European Union EN     (e)  make public any additional data and information for whic h the conf identiality request has not been accept ed as 
justified at the earliest two weeks after the notification of its decision to the applicant has taken place pursuant 
to point (d). 
2. Within two weeks of the notific ation of the Auth ority's decision on the conf identiality request to the 
applicant pursuant to paragraph 1, the applicant may submit a confir matory application asking the Author ity to 
reconsider its decision. The conf irmatory application shall have suspensive effect. The Auth ority shall examine the 
grounds for the conf irmatory application and shall adopt a reasoned decision on that conf irmat ory application. It 
shall notify the applicant of that decision within three week s of submitting the confir matory application and shall 
include in that notific ation information on the available remedies, namely an action before the Cour t of Justice of 
the European Union (the “Cour t of Justice”) against the Auth ority pursuant to paragraph 3. The Author ity shall 
mak e public any additional data and information for which the conf identiality request has not been accept ed by 
the Author ity as justified, at the earliest two weeks after the notification of the Authority's reasoned decision on 
the confir matory application to the applicant has taken place pursuant to this paragraph. 
3. Decisions take n by the Authority pursuant to this Article may be subject to an action before the Cour t of 
Justice, under the conditions laid down in Articles 263 and 278 of the Treaty on the Functioning of the European 
Union (TFEU) respectively . 
Article 39c 
Review of conf identiality 
Before the Author ity issues its scientific outputs, including scientific opinions, it shall review whether information 
that has been previously accept ed as conf idential may never theless be made public in accordance with point (b) of 
Article 39(4). Should that be the case, the Author ity shall follow the procedure laid down in Article 39b, which 
shall apply mutatis mutandis. 
Article 39d 
Obligations with regard to conf identiality 
1. The Authority shall make available, upon request, to the Commission and the Member States all information 
in its possession relating to an application or to a request by the European Parliament, by the Commission or by 
the Member States for a scientifi c output, including a scientifi c opinion, unless other wise indicated in Union law. 
2. The Commission and the Member States shall take the necessar y measures so that information received by 
them under Union law for which conf idential treatment has been requeste d is not made public until a decision on 
the confidentiality request has been take n by the Authority and has become final. The Commission and the 
Member States shall also take the necessar y measures so that information for which confidential treatment has 
been accept ed by the Author ity is not made public. 
3. If an applicant withdraws or has withdra wn an application, the Author ity, the Commission and the Member 
States shall respect the confidentiality of information as grant ed by the Author ity in accordance with Articles 39 
to 39e. The application shall be considered withdra wn as of the moment the written request to that effect is 
received by the compet ent body that had received the original application. Where the withdra wal of the application 
takes place before a final decision on the conf identiality request has been adopt ed by the Author ity pursuant to, 
where appropr iate, Article 39b(1) or (2), the Commission, the Member States and the Auth ority, shall not make 
public the information for whic h conf identiality has been request ed. 
4. Members of the Managem ent Board, the Executive Director , members of the Scientific Committ ee and 
Scientific Panels as well as extern al exper ts participating in their working groups, members of the Advisor y Forum 
and members of the staff of the Author ity, even after their duties have ceased, shall be subject to the requirements 
of the obligation of professional secrecy pursuant to Article 339 TFEU. 
5. The Author ity shall lay down in consultation with the Commission the practical arrange ments for 
implementing the confidentiality rules laid down in Articles 39, 39a, 39b, 39e and in this Article, including 
arrang ements concer ning the submission and treatment of conf identiality requests with respect to information to 
be made public under Article 38, and taking into account Articles 39f and 39g. As regards Article 39b(2), the 
Author ity shall ensure that appropr iate separation of tasks is applied for the assessment of conf irmat ory 
applications. 6.9.2019 L 231/15 Official Jour nal of the European Union EN     Article 39e 
Protection of personal data 
1. With respect to requests for scientifi c outputs, including scientifi c opinions under Union law, the Author ity 
shall alwa ys mak e public: 
(a)  the name and address of the applicant ; 
(b)  the names of authors of published or publicly available studies suppor ting such requests; and 
(c)  the names of all participants and obser vers in meetings of the Scientific Committ ee and the Scientific Panels, 
their working groups and any other ad hoc group meeting on the subject matt er. 
2. Notwithstanding paragraph 1, disclosure of names and addresses of natural persons involved in testing on 
vertebrate animals or in obtaining toxicological information shall be deemed to significantly harm the privacy and 
the integrity of those natural persons and shall not be made publicly available unless other wise specifi ed in 
Regulations (EU) 2016/679 (*) and (EU) 2018/1725 (**) of the European Parliament and of the Council. 
3. Regulations (EU) 2016/679 and (EU) 2018/1725 shall apply to the processing of personal data carried out 
pursuant to this Regulation. Any personal data made public pursuant to Article 38 of this Regulation and this 
Article shall only be used to ensure the transparency of the risk assessment under this Regulation and shall not be 
further processed in a manner that is incompatible with these purposes, in accordance with point (b) of 
Article 5(1) of Regulation (EU) 2016/679 and point (b) of Article 4(1) of Regulation (EU) 2018/1725, as the case 
may be. 
Article 39f 
Standard data formats 
1. For the purposes of point (c) of Article 38(1) and in order to ensure the efficient processing of requests to 
the Author ity for a scientific output, standard data formats shall be adopt ed in accordance with paragraph 2 of this 
Article to allow documents to be submitted , searc hed, copied and printed, while ensur ing compl iance with 
regulatory requirements set out in Union law. Those standard data formats shall: 
(a)  not be based on propr ietar y standards; 
(b)  ensure inter operability with existing data submission approaches to the extent possible; 
(c)  be user -friendly and adap ted for the use by small and medium-sized enterprises. 
2. For the adoptio n of standard data formats refer red to in paragraph 1, the following procedure shall be 
followed: 
(a)  the Author ity shall draw up draf t standard data formats for the purposes of the diffe rent author isation 
procedures and relevant requests for a scientific output by the European Parliament, by the Commission and by 
the Member States; 
(b)  the Commission shall, taking into account the applicable requirements in the different author isation procedures 
and other legal framew orks and following any necessar y adap tations, adop t, by means of implementing acts, 
standard data formats. Those imple menting acts shall be adopt ed in accordance with the procedure refer red to 
in Article 58(2); 
(c)  the Authority shall mak e the standard data formats, as adopt ed, available on its website; 
(d)  where standard data formats have been adopt ed pursuant to this Article, applications as well as requests for 
a scientifi c output, including a scientifi c opinion by the European Parliament, by the Commission and by the 
Member States, shall only be submitte d in accordance with those standard data formats. 6.9.2019 L 231/16 Official Jour nal of the European Union EN     Article 39g 
Information systems 
The information systems operat ed by the Author ity to store its data, including confidential and personal data shall 
be designed in a way that guarant ees that any access to it is fully auditable and that the highest standards of 
secur ity appropr iate to the secur ity risks at stake are attained, taking into account Articles 39 to 39f.  
(*)Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 Apr il 2016 on the protection 
of natural persons with regard to the processing of personal data and on the free movement of such data and 
repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). 
(**) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the 
prote ction of natural persons with regard to the processing of personal data by the Union institutions, bodies, 
office s and agencies and on the free mov ement of such data, and repealing Regulation (EC) No 45/2001 and 
Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).’;  
(10) in Article 40(3), the second subparagraph is replaced by the following: 
‘The Author ity shall make public all scientific outputs including the scientific opinions issued by it and suppor ting 
scientific data and other information in accordance with Articles 38 to 39e.’;  
(11) Article 41 is amended as follows: 
(a)  paragraph 1 is replaced by the following: 
‘1. Notwithstanding the rules on conf identiality provid ed for in Articles 39 to 39d of this Regulation, 
Regulation (EC) No 1049/2001 of the European Parliament and of the Council (*) shall apply to documents 
held by the Author ity. 
Where environmental information is concer ned, Regulation (EC) No 1367/2006 of the European Parliament 
and of the Council (**) shall also apply . Directive 2003/4/EC of the European Parliament and of the 
Council (***) shall apply to environmental information held by Member State s, notwithstanding the rules on 
confidentiality provided for in Articles 39 to 39d of this Regulation.  
(*)Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding 
public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). 
(**) Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 Sept ember 2006 on 
the application of the provis ions of the Aarhus Conv ention on Access to Information, Public Participation 
in Decision-making and Access to Justice in Environmental Matte rs to Community institutions and bodies 
(OJ L 264, 25.9.2006, p. 13). 
(***) Directive 2003/4/EC of the European Parliament and of the Council of 28 Januar y 2003 on public access 
to envi ronmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26).’; 
(b)  paragraph 2 is replaced by the following: 
‘2. The Manage ment Board shall adopt the practical arrangements for implementing Regulation (EC) 
No 1049/2001 and Articles 6 and 7 of Regulation (EC) No 1367/2006 by 27 March 2020, ensur ing as wide 
access as possible to documents in its possession.’;  
(12) Article 61 is replaced by the followi ng: 
‘Article 61 
Review clause 
1. The Commission shall ensure the regular review of the application of this Regulation. 
2. By 28 March 2026, and ever y five years thereaf ter, the Commission shall evaluate the Author ity's 
perf ormance in relation to its objectives, mandat e, tasks, procedures and location, in accordance with Commission 
guidelines. That evaluation shall also cover the impact of Article 32a on the functioning of the Auth ority with 
particular attention to the relevant workload and mobilisation of staff, and to any shifts in the allocation of the 
Author ity's resources that may have take n place, at the expense of activities of public interest. That evaluation shall 
address the possible need to modify the mandate of the Authority, and the financial implications of any such 
modification. 6.9.2019 L 231/17 Official Jour nal of the European Union EN     3. In the evaluation refer red to in paragraph 2, the Commission shall also evaluate whether the organisational 
framew ork of the Author ity needs to be further update d with regard to decisions on requests for confidentiality 
and conf irmat ory applications, namely by setting up a specific Board of Appeal or by other appropr iate means. 
4. Where the Commission considers that the continued operation of the Author ity is no long er justif ied with 
regar d to its assigned objectives, mandate and task s, it may propose that the relevant provisions of this Regulation 
be amended according ly or repealed. 
5. The Commission shall repor t to the European Parliament, to the Council and to the Managem ent Board on 
the findings of its reviews and evaluations under this Article. Those findings shall be made public.’;  
(13) the follo wing Article is inser ted: 
‘Article 61a 
Fact-f inding missions 
Commission exper ts shall perform fact-finding missions in Member States to assess the application, by laboratories 
and by other testing facilities, of the relevant standards for carrying out tests and studies submitt ed to the 
Author ity as part of an application, as well as compl iance with the notification obligation set out in Article 32b(3), 
by 28 March 2025. By that date, Commission exper ts shall also perf orm fact-fi nding missions to assess the 
application of those standards by laborat ories and other testing facilities locat ed in third countr ies insof ar as set out 
in relevant agreements and arrang ements with those third countr ies, including as refer red to in Article 49. 
Non-compli ance identif ied during those fact-fi nding missions shall be brought to the attention of the Commission, 
Member States, the Auth ority as well as the assessed laborat ories and other testing facilities. The Commission, the 
Author ity and Member States shall ensure the appropr iate follow-up to such identif ied non-com pliance. 
The outcome of these fact-finding missions shall be presented in an overview repor t. On the basis of that repor t, 
the Commission shall submit a legislative proposal, if appropr iate, as regards, in particular , any necessar y control 
procedures, including audits.’. 
Article 2 
Amendments to Regulation (EC) No 1829/2003 
Regulation (EC) No 1829/2003 is amended as follo ws:  
(1) in Article 5, paragraph 3 is amended as follows: 
(a)  the introduct ory wording is replaced by the followi ng: 
‘The application shall be submitted in accordance with standard data formats, where they exist pursuant to 
Article 39f of Regulation (EC) No 178/2002, and shall be accompanied by the follo wing:’; 
(b)  point (l) is replaced by the follo wing: 
‘(l)  an identification of the parts of the application and any other supplementar y information that the applicant 
requests to be treated as confidential, accompan ied by verifiable justification, pursuant to Article 30 of this 
Regulation and Article 39 of Regulation (EC) No 178/2002;’; 
(c)  the follo wing point is added: 
‘(m)  a summar y of the dossier in a standardised form.’;  
(2) in Article 6, paragraph 7 is replaced by the followi ng: 
‘7. The Auth ority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion 
public, after deletion of any information identif ied as confidential in accordance with Articles 39 to 39e of 
Regulation (EC) No 178/2002 and Article 30 of this Regulation. The public may mak e comments to the 
Commission within 30 days of such publication.’;  
(3) in Article 10, paragraph 1 is replaced by the followi ng: 
‘1. On its own initiative or followi ng a request from the Commission or from a Member State , the Author ity 
shall issue an opinion on whether an author isation for a product refer red to in Article 3(1) of this Regulation still 
meets the conditions set out in this Regulation. It shall forthwith transmit that opinion to the Commission, 
Member States and the author isation-holder . The Author ity, in accordance with Article 38(1) of Regulation (EC) 
No 178/2002, shall mak e its opinion public, after deletion of any information identified as confidential in 
accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 30 of this Regulation. The public 
may make comments to the Commission within 30 days of such publication.’; 6.9.2019 L 231/18 Official Jour nal of the European Union EN     (4) in Article 11(2), the introductor y wording is replaced by the follo wing: 
‘2. The application shall be submitted in accordance with standard data formats, where they exist pursuant to 
Article 39f of Regulation (EC) No 178/2002, and accompanied by the following:’;  
(5) in Article 17, paragraph 3 is amended as follows: 
(a)  the introduct ory wording is replaced by the followi ng: 
‘The application shall be submitted in accordance with standard data formats, where they exist pursuant to 
Article 39f of Regulation (EC) No 178/2002, and accompanied by the follo wing:’; 
(b)  point (l) is replaced by the follo wing: 
‘(l)  an identification of the parts of the application and any other supplementar y information that the applicant 
requests to be treated as confidential, accompan ied by verifiable justification, pursuant to Article 30 of this 
Regulation and Articles 39 to 39e of Regulation (EC) No 178/2002;’; 
(c)  the follo wing point is added: 
‘(m)  a summar y of the dossier in a standardised form.’;  
(6) in Article 18, paragraph 7 is replaced by the followi ng: 
‘7. The Author ity shall, in accordance with Article 38(1) of Regulation (EC) No 178/2002, make its opinion 
public, after the deletion of any information identif ied as conf idential in accordance with Articles 39 to 39e of 
Regulation (EC) No 178/2002 and Article 30 of this Regulation. The public may mak e comments to the 
Commission within 30 days of such publication.’;  
(7) in Article 22, paragraph 1 is replaced by the followi ng: 
‘1. On its own initiative or followi ng a request from the Commission or from a Member State , the Author ity 
shall issue an opinion on whether an author isation for a product referred to in Article 15(1) still meets the 
conditions set out in this Regulation. It shall forthwith transmit that opinion to the Commission, Member States 
and the author isation-holder . The Author ity, in accordance with Article 38(1) of Regulation (EC) No 178/2002, 
shall make its opinion public, after deletion of any information identif ied as conf idential in accordance with 
Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 30 of this Regulation. The public may make 
comments to the Commission within 30 days of such publication.’;  
(8) in Article 23(2), the introductor y wording is replaced by the follo wing: 
‘2. The application shall be submitted in accordance with standard data formats, where they exist pursuant to 
Article 39f of Regulation (EC) No 178/2002, and accompanied by the following:’;  
(9) in Article 29, paragraphs 1 and 2 are replaced by the followi ng: 
‘1. The Auth ority shall mak e public the application for author isation, relevant suppor ting information and any 
supplementar y information supplied by the applicant, as well as its scientifi c opinions and opinions from the 
compet ent author ities refer red to in Article 4 of Directive 2001/18/EC, in accordance with Articles 38 to 39e of 
Regulation (EC) No 178/2002 and taking into account Article 30 of this Regulation. 
2. The Auth ority shall apply Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 
30 May 2001 rega rding public access to European Parliament, Council and Commission documents (*) when 
handling applications for access to documents held by the Authority.  
(*)Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding 
public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).’;  
(10) Article 30 is replaced by the followi ng: 
‘Article 30 
Conf identiality 
1. In accordance with the conditions and the procedures laid down in Articles 39 to 39e of Regulation (EC) 
No 178/2002 and this Article: 
(a)  the applicant may submit a request to treat certain parts of the information submitted under this Regulation as 
confidential, accompan ied by verifiable justification; and 
(b)  the Authority shall assess the conf identiality request submitted by the applicant. 6.9.2019 L 231/19 Official Jour nal of the European Union EN     2. In addition to the items of information referred to in points (a), (b) and (c) of Article 39(2) of Regulation (EC) 
No 178/2002 and pursuant to Article 39(3) thereof, the Author ity may also grant conf idential treatment with 
respect to the followi ng information, where the disclosure of such information is demonstrated by the applicant to 
poten tially harm its inter ests to a signif icant degree: 
(a) DNA sequence information, excep t for sequences used for the purpose of detection, identif ication and quantifi ­
cation of the transf ormation event ; and 
(b)  breeding patt erns and strateg ies. 
3. The use of the detection methods and the reproduction of the referen ce mate rials, provided under 
Articles 5(3) and 17(3) for the purpose of applying this Regulation to GMOs, food or feed to whic h an application 
refers, shall not be restr icted by the exercise of intellectua l proper ty rights or other wise. 
4. This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.’. 
Article 3 
Amendments to Regulation (EC) No 1831/2003 
Regulation (EC) No 1831/2003 is amended as follo ws:  
(1) Article 7 is amended as follows : 
(a)  paragraph 1 is replaced by the followi ng: 
‘1. An application for an author isation as provided for in Article 4 of this Regulation shall be sent to the 
Commission, in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation 
(EC) No 178/2002, whic h shall apply mutatis mutandis. The Commission shall without dela y inform the Member 
States and forward the application to the European Food Safety Auth ority (hereinaf ter refer red to as the 
“Auth ority”).’; 
(b)  in paragraph 2, point (c) is replaced by the follo wing: 
‘(c)  make public the application and any information supplied by the applicant, in accordance with Article 18.’;  
(2) Article 18 is replaced by the followi ng: 
‘Article 18 
Transparency and conf identiality 
1. The Author ity shall mak e public the application for author isation, relevant suppor ting information and any 
supplementar y information supplied by the applicant, as well as its scientifi c opinions, in accordance with 
Articles 38 to 39e of Regulation (EC) No 178/2002, which shall apply mutatis mutandis. 
2. In accordance with the conditions and the procedures laid down in Articles 39 to 39e of Regulation (EC) 
No 178/2002 and in this Article, the applicant may submit a request to treat certain parts of the information 
submitted under this Regulation as confidential, accompanied by verifiable justif ication. The Author ity shall assess 
the confidentiality request submitted by the applicant. 
3. In addition to the items of information refer red to in Article 39(2) of Regulation (EC) No 178/2002 and 
pursuant to Article 39(3) thereof, the Author ity may also grant conf idential treatment with respect to the followi ng 
items of information, where the disclosure of such information is demonstrated by the applicant to poten tially harm 
its interests to a signif icant degree: 
(a)  the study plan for studies demonstrating the efficacy of a feed additive in term s of the aims of its intended use as 
defined in Article 6(1) of, and Annex I to, this Regulation; and 
(b)  specifications of the impur ities of the active substance and the relevant methods of analysis developed internall y 
by the applicant, excep t for impur ities that may have adverse effects on animal health, human health, or the 
environment. 
4. This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.’. 6.9.2019 L 231/20 Official Jour nal of the European Union EN     Article 4 
Amendments to Regulation (EC) No 2065/2003 
Regulation (EC) No 2065/2003 is amended as follo ws:  
(1) Article 7 is amended as follows : 
(a)  in paragraph 2, point (c) is replaced by the follo wing: 
‘(c)  The Auth ority shall: 
(i)  inform without dela y the Commission and the other Member States of the application and shall make 
the application and any supplementar y information supplied by the applicant available to them; and 
(ii)  mak e public the application, relevant suppor ting information and any supplementar y information 
supplied by the applicant, in accordance with Articles 14 and 15.’; 
(b)  paragraph 4 is replaced by the followi ng: 
‘4. The Auth ority shall publish detailed guidance, followi ng the agreement with the Commission, concer ning 
the preparation and the submission of the application, refer red to in paragraph 1 of this Article, taking into 
account standard data formats, where they exist in accordance with Article 39f of Regulation (EC) 
No 178/2002.’;  
(2) in Article 14, paragraph 1 is replaced by the followi ng: 
‘1. The Author ity shall make public the application for author isation, relevant suppor ting information and any 
supplementar y information supplied by the applicant as well as its scientific opinions, in accordance with 
Articles 38 to 39e of Regulation (EC) No 178/2002.’;  
(3) Article 15 is replaced by the followi ng: 
‘Article 15 
Conf identiality 
1. In accordance with the conditions and the procedures laid down in Articles 39 to 39e of Regulation (EC) 
No 178/2002: 
(a)  the applicant may submit a request to treat certain parts of the information submitted under this Regulation as 
confidential, accompanied by verifiable justif ication; and 
(b)  the Author ity shall assess the conf identiality request submitted by the applicant. 
2. This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.’. 
Article 5 
Amendments to Regulation (EC) No 1935/2004 
Regulation (EC) No 1935/2004 is amended as follo ws:  
(1) Article 9 is amended as follows : 
(a)  in paragraph 1, point (c) is replaced by the follo wing: 
‘(c)  the Author ity shall without dela y: 
(i)  inform the Commission and the other Member States of the application and shall make the application 
and any supplementar y information supplied by the applicant available to them; and 
(ii)  mak e public the application, relevant suppor ting information and any supplementar y information 
supplied by the applicant, in accordance with Articles 19 and 20.’; 
(b)  paragraph 2 is replaced by the followi ng: 
‘2. The Author ity shall publish detailed guidelines, followi ng the agreement with the Commission, concer ning 
the preparation and the submission of the application, taking into account standard data formats, where they 
exist in accordance with Article 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.’;  
(2) in Article 19, paragraph 1 is replaced by the followi ng: 
‘1. The Author ity shall make public the application for author isation, relevant suppor ting information and any 
supplementar y information supplied by the applicant, as well as its scientifi c opinions, in accordance with 
Articles 38 to 39e of Regulation (EC) No 178/2002, which shall apply mutatis mutandis, and with Article 20 of this 
Regulation.’; 6.9.2019 L 231/21 Official Jour nal of the European Union EN     (3) Article 20 is replaced by the followi ng: 
‘Article 20 
Conf identiality 
1. In accordance with the conditions and the procedures laid down in Articles 39 to 39e of Regulation (EC) 
No 178/2002 and in this Article: 
(a)  the applicant may submit a request to treat certain parts of the information submitted under this Regulation as 
confidential, accompanied by verifiable justif ication; and 
(b)  the Author ity shall assess the conf identiality request submitted by the applicant. 
2. In addition to the items of information refer red to in Article 39(2) of Regulation (EC) No 178/2002 and 
pursuant to Article 39(3) thereof, the Author ity may also grant conf idential treatment with respect to the followi ng 
items of information, where the disclosure of such information is demonstrated by the applicant to poten tially harm 
its interests to a signif icant degree: 
(a)  any information provided in detailed descr iptions of starting substances and mixtures used to manufacture the 
substance subject to the author isation, the compo sition of mixtures, mater ials or articles in which the applicant 
intends to use that substance, the manufa ctur ing methods of those mixtures, mater ials or articles, imp urities, 
and migration testing results, excep t for information which is relevant to the assessment of safety ; 
(b)  the trademark under which the substance shall be market ed as well as the tradename of the mixtures, mat erial 
or articles in whic h it shall be used, where applicable; and 
(c)  any other information deemed conf idential within the specifi c procedural rules refer red to in point (n) of 
Article 5(1) of this Regulation. 
3. This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.’. 
Article 6 
Amendments to Regulation (EC) No 1331/2008 
Regulation (EC) No 1331/2008 is amended as follo ws:  
(1) in Article 6, the followi ng paragraph is added: 
‘5. The Author ity shall make public the additional information supplied by the applicant in accordance with 
Articles 11 and 12.’;  
(2) Article 11 is replaced by the followi ng: 
‘Article 11 
Transparency 
Where the Commission requests the opinion of the Author ity in accordance with Article 3(2) of this Regulation, the 
Author ity shall make public without dela y the application for author isation, relevant suppor ting information and 
any supplementar y information supplied by the applicant, as well as its scientifi c opinions, in accordance with 
Articles 38 to 39e of Regulation (EC) No 178/2002. The Author ity shall also make public any request for its 
opinion as well as any extensi on of period pursuant to Article 6(1) of this Regulation.’;  
(3) Article 12 is replaced by the followi ng: 
‘Article 12 
Conf identiality 
1. The applicant may submit a request to treat certain parts of the information submitted under this Regulation 
as conf idential, accompan ied by verifiable justification, upon submission of the application. 
2. Where an opinion by the Auth ority is required in accordance with Article 3(2) of this Regulation, the 
Author ity shall assess the confidentiality request submitte d by the applicant, in accordance with Articles 39 to 39e 
of Regulation (EC) No 178/2002. 6.9.2019 L 231/22 Official Jour nal of the European Union EN     3. In addition to the items of information refer red to in Article 39(2) of Regulation (EC) No 178/2002 and 
pursuant to Article 39(3) thereof, the Author ity may also grant conf idential treatment with respect to the followi ng 
items of information, where the disclosure of such information is demonstrated by the applicant to poten tially harm 
its interests to a signif icant degree: 
(a)  where applicable, information provided in detailed descr iptions of starting substances and starting preparations 
and on how they are used to manuf acture the substance subject to the author isation, and detailed information 
on the nature and compo sition of the mate rials or products in which the applicant intends to use the substance 
subject to the author isation, excep t for information which is relevant to the assessment of safety ; 
(b)  where applicable, detailed analytical information on the variability and stability of individual production batch es 
of the substance subject to the author isation, excep t for information which is relevant to the assessment of 
safet y. 
4. Where an opinion by the Authority is not required in accordance with Article 3(2) of this Regulation, the 
Commission shall assess the confidentiality request submitted by the applicant. Articles 39, 39a and 39d of 
Regulation (EC) No 178/2002 and paragraph 3 of this Article shall apply mutatis mutandis. 
5. This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.’. 
Article 7 
Amendments to Regulation (EC) No 1107/2009 
Regulation (EC) No 1107/2009 is amended as follo ws:  
(1) Article 7 is amended as follows : 
(a)  in paragraph 1, the first subparagraph is replaced by the followi ng: 
‘An application for the approval of an active substance or for an amendment to the conditions of an appro val 
shall be submitted by the producer of the active substance to a Member State (the “rappor teur Member State”), 
together with a summar y and a compl ete dossier as provid ed for in Article 8(1) and (2) of this Regulation or 
a scientific ally reasoned justif ication for not provid ing certain parts of those dossiers, demonstrating that the 
active substance fulfils the appro val criteria provided for in Article 4 of this Regulation. The application shall be 
submitte d in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) 
No 178/2002, which shall apply mutatis mutandis.’; 
(b)  paragraph 3 is replaced by the followi ng: 
‘3. When submitting the application, the applicant may submit a request, pursuant to Article 63, to treat 
certain information, including certain parts of the dossier , as confidential and shall physically separate that 
information. 
Member States shall assess the confidentiality requests. After consultation with the Author ity, the rappor teur 
Member State s shall decide what information is to be treated as conf idential, in accordance with Article 63. 
The Author ity, followi ng consultations with the Member States, shall lay down practical arrangements to ensure 
the consiste ncy of those assessments.’;  
(2) Article 10 is replaced by the followi ng: 
‘Article 10 
Public access to the dossiers 
The Auth ority shall without dela y make the dossiers refer red to in Article 8, including any supplementar y 
information supplied by the applicant, available to the public, with the excep tion of any information to which the 
rappor teur Member State has grant ed conf idential treatment pursuant to Article 63.’;  
(3) In Article 15, paragraph 1 is replaced by the followi ng: 
‘1. The application provided for in Article 14 of this Regulation shall be submitted by a producer of the active 
substance to a Member State , with a copy to the Commission, to the other Member States and to the Author ity, no 
later than three years before the expir y of the approval. The application shall be submitted in accordance with 
standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, whic h shall apply 
mutatis mutandis.’; 6.9.2019 L 231/23 Official Jour nal of the European Union EN     (4) Article 16 is replaced by the followi ng: 
‘Article 16 
Public access to the information for renewal 
The Author ity shall assess, without dela y, any conf identiality request and make available to the public the 
information provided by the applicant under Article 15 as well as any other supplementar y information submitted 
by the applicant, excep t for information in respect of whic h confidential treatment has been request ed and grant ed 
by the Author ity pursuant to Article 63. 
The Authority, following consultations with the Member States, shall lay down practical arrang ements to ensure the 
consistency of those assessments.’;  
(5) in Article 63, paragraphs 1, 2 and 3 are replaced by the followi ng: 
‘1. An applicant may submit a request to treat certain parts of the information submitted under this Regulation 
as conf idential, accompan ied by verifiable justification. 
2. Confi dential treatment may be grant ed only with respect to the followi ng items of information, where the 
disclosure of such information is demonstrate d by the applicant to potentially harm its interests to a significant 
degree: 
(a)  information referred to in Article 39(2) of Regulation (EC) No 178/2002; 
(b)  the specifi cation of impurity of the active substance and the related methods of analysis for impurities in the 
active substance as manufactured, excep t for the impur ities that are considered to be toxicologically , ecoto xicolo ­
gically or environmentally relevant and the relat ed methods of analysis for such impurities; 
(c)  results of production batc hes of the active substance including impurities; and 
(d)  information on the complet e compo sition of a plant protection product. 
2a. Where the Auth ority assesses conf identiality requests under this Regulation, the conditions and the 
procedures laid down in Articles 39 to 39e of Regulation (EC) No 178/2002 and paragraph 2 of this Article shall 
apply . 
2b. Where Member States assess conf identiality requests under this Regulation, the following requirements and 
procedures apply: 
(a)  confidentiality treatment may only be grant ed with respect to information liste d in paragraph 2; 
(b)  where the Member State has decided which information is to be treated as confidential, it shall inform the 
applicant of its decision; 
(c)  Member States, the Commission and the Auth ority shall take the necessar y measures so that information for 
whic h confidential treatment has been granted is not made public; 
(d)  Article 39e of Regulation (EC) No 178/2002 shall apply mutatis mutandis; 
(e)  notwithstanding paragraph 2 and points (c) and (d) of this paragraph: 
(i)  where urgent action is essential to protect human health, animal health or the environment, such as in 
emerg ency situations, the Member State may disclose the information refer red to in paragraph 2; 
(ii)  information which forms part of the conclusions of the scientific outputs delivered by the Authority and 
whic h relat e to foreseeable effects on human health, animal health or the envi ronment shall never theless be 
made public. In that case, Article 39c of Regulation (EC) No 178/2002 shall apply ; 
(f)  if the applicant withdraws or has withdrawn an application, Member States, the Commission and the Author ity 
shall respect the conf identiality as grant ed in accordance with this Article. Where the withdra wal of the 
application take s place before the Member State has decided on the relevant confidentiality request, Member 
States, the Commission and the Authority shall not make public the information for which conf identiality has 
been requeste d. 6.9.2019 L 231/24 Official Jour nal of the European Union EN     3. This Article is without prejudice to Directive 2003/4/EC (*) and Regulations (EC) No 1049/2001 (**) and (EC) 
No 1367/2006 (***) of the European Parliament and of the Council.  
(*)Directive 2003/4/EC of the European Parliament and of the Council of 28 Januar y 2003 on public access to 
environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26). 
(**) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding 
public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). 
(***) Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 Sept ember 2006 on the 
application of the provis ions of the Aarhus Convention on Access to Information, Public Participation in 
Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies 
(OJ L 264, 25.9.2006, p. 13).’. 
Article 8 
Amendments to Regulation (EU) 2015/2283 
Regulation (EU) 2015/2283 is amended as follo ws:  
(1) Article 10 is amended as follows: 
(a)  paragraph 1 is replaced by the followi ng: 
‘1. The procedure for author ising the placing on the market within the Union of a novel food and updating 
of the Union list provi ded for in Article 9 of this Regulation shall start either on the Commission's initiative or 
following an application to the Commission by an applicant, in accordance with standard data formats, where 
they exist pursuant to Article 39f of Regulation (EC) No 178/2002. The Commission shall make the application 
available to the Member States without dela y. The Commission shall make a summar y of the application, based 
on the information refer red to in points (a), (b) and (e) of paragraph 2 of this Article, publicly available.’; 
(b)  paragraph 3 is replaced by the followi ng: 
‘3. Where the Commission requests an opinion from the European Food Safet y Authority (the “Author ity”), 
the Authority shall make public the application in accordance with Article 23 and shall give its opinion as to 
whether the update is liable to have an effect on human health.’;  
(2) in Article 15, paragraph 2 is replaced by the followi ng: 
‘2. Within four months from the date on which a valid notifi cation is forwarded by the Commission in 
accordance with paragraph 1 of this Article, a Member State or the Author ity may submit to the Commission duly 
reasoned safety objections to the placing on the market within the Union of the traditional food concer ned. Where 
the Authority submits duly reasoned safet y objections, it shall mak e public, without dela y, the notificati on, pursuant 
to Article 23, whic h shall apply mutatis mutandis.’;  
(3) Article 16 is amended as follows: 
(a)  in the first paragraph, the following senten ce is added: 
‘The application shall be submitted in accordance with standard data formats, where they exist pursuant to 
Article 39f of Regulation (EC) No 178/2002.’; 
(b)  in the second paragraph, the following senten ce is added: 
‘The Author ity shall make public the application, relevant suppor ting information and any supplementar y 
information supplied by the applicant in accordance with Article 23.’;  
(4) Article 23 is replaced by the followi ng: 
‘Article 23 
Transparency and conf identiality 
1. Where the Commission requests the opinion of the Author ity in accordance with Article 10(3) and Article 16 
of this Regulation, the Author ity shall make public the application for author isation, relevant suppor ting 
information and any supplementar y information supplied by the applicant, as well as its scientifi c opinions, in 
accordance with Articles 38 to 39e of Regulation (EC) No 178/2002 and with this Article. 6.9.2019 L 231/25 Official Jour nal of the European Union EN     2. The applicant may submit a request to treat certain parts of the information submitted under this Regulation 
as conf idential, accompan ied by verifiable justification, upon submission of the application. 
3. Where the Commission requests the opinion of the Author ity in accordance with Article 10(3) and Article 16 
of this Regulation, the Author ity shall assess the confidentiality request submitted by the applicant in accordance 
with Articles 39 to 39e of Regulation (EC) No 178/2002. 
4. In addition to the items of information refer red to in Article 39(2) of Regulation (EC) No 178/2002 and 
pursuant to Article 39(3) thereof, the Author ity may also grant conf idential treatment with respect to the followi ng 
items of information, where the disclosure of such information is demonstrated by the applicant to poten tially harm 
its interests to a signif icant degree: 
(a)  where applicable, information provided in detailed descr iptions of starting substances and starting preparations 
and on how they are used to manuf acture the novel food subject to the author isation, and detailed information 
on the nature and compo sition of the specifi c foods or food catego ries in which the applicant intends to use 
that novel food, exce pt for information which is relevant to the assessment of safety ; 
(b)  where applicable, detailed analytical information on the variability and stability of individual production batche s, 
excep t for information which is relevant to the assessment of safety . 
5. Where the Commission does not request the Auth ority's opinion pursuant to Articles 10 and 16 of this 
Regulation, the Commission shall assess the conf identiality request submitted by the applicant. Articles 39, 39a 
and 39d of Regulation (EC) No 178/2002 and paragraph 4 of this Article shall apply mutatis mutandis. 
6. This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.’. 
Article 9 
Amendments to Directiv e 2001/18/EC 
Directive 2001/18/EC is amended as follo ws:  
(1) in Article 6, the followi ng paragraph is inser ted: 
‘2a. The notification refer red to in paragraph 1 shall be submitte d in accordance with standard data formats, 
where they exist under Union law.’;  
(2) in Article 13, the following paragraph is inser ted: 
‘2a. The notification refer red to in paragraph 1 shall be submitte d in accordance with standard data formats, 
where they exist under Union law.’;  
(3) Article 25 is replaced by the followi ng: 
‘Article 25 
Conf identiality 
1. The notifier may submit a request to the compet ent author ity to treat certain parts of the information 
submitted under this Directive as conf idential, accompanied by verifiable justif ication, in accordance with paragraphs 
3 and 6. 
2. The compet ent author ity shall assess the conf identiality request submitted by the notifier . 
3. Upon request of a notifier , the compet ent author ity may grant conf idential treatment only with respect to the 
followi ng items of information, upon verifiable justif ication, where the disclosure of such information is 
demonstrated by the notifier to pote ntially harm its inter ests to a signif icant degree: 
(a)  items of information refer red to in points (a), (b) and (c) of Article 39(2) of Regulation (EC) No 178/2002; 
(b) DNA sequence information, excep t for sequences used for the purpose of detection, identification and quantifi ­
cation of the transf ormation event ; and 
(c)  breeding patter ns and strateg ies. 
4. The compe tent author ity shall, after consultation with the notifier , decide whic h information is to be treated as 
conf idential and shall inform the notifi er of its decision. 6.9.2019 L 231/26 Official Jour nal of the European Union EN     5. Member States, the Commission and the relevant Scientific Committ ee(s) shall take the necessar y measures to 
ensure that confidential information notified or exchanged under this Directive is not made public. 
6. The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis. 
7. Notwithstanding paragraphs 3, 5 and 6 of this Article: 
(a)  where urgent action is essential to prot ect human health, animal health or the environment, such as in 
emerg ency situations, the compet ent author ity may disclose the information refer red to in paragraph 3; and 
(b)  information whic h forms part of the conclusions of the scientifi c outputs delivered by the relevant Scientifi c 
Committ ee(s) or the conclusions of the assessment repor ts and which relat e to foreseeable effects on human 
health, animal health or the environment shall never theless be made public. In that case, Article 39c of 
Regulation (EC) No 178/2002 shall apply . 
8. In the event of a withdra wal of the notification by the notifi er, Member State s, the Commission and the 
relevant Scientific Committee(s) shall respect the conf identiality as granted by the compet ent author ity in accordance 
with this Article. Where the withdra wal of the notification take s place before the compet ent author ity has decided 
on the relevant confidentiality request, Member States, the Commission and the relevant Scientifi c Committ ee(s) 
shall not make public the information for whic h confidentiality has been requested.’;  
(4) in Article 28, the following paragraph is added: 
‘4. Where the relevant Scientific Committ ee is consult ed in accordance with paragraph 1 of this Article, it shall 
make public without dela y the notifi cation, relevant suppor ting information and any supplementar y information 
supplied by the notifi er, as well as its scientific opinions, with the excep tion of any information to which the 
compet ent author ity has grant ed conf idential treatment in accordance with Article 25.’. 
Article 10 
Transitional measures 
1. This Regulation shall not apply to applications under Union law as well as requests for scientific outputs submitte d 
to the Authority before 27 March 2021. 
2. The term of office of the members of the Manag ement Board of the Author ity (the ‘Manag ement Board’) who are 
in office on 30 June 2022, shall expire on that date. Notwithstanding the date s of application refer red to in Article 11, 
the procedure for nomination and appointment of members to the Management Board set out in point 4 of Article 1 
shall apply for the purposes of allowing the members appointed under those rules to start their term of office on 1 July 
2022. 
3. Notwithstanding the date s of application referred to in Article 11, the term of office of the members of the 
Scientific Committee and of the Scientific Panels who are in office on 30 June 2021, shall be prolonged until the 
members of that Scientific Committee and those Scientific Panels appointe d according to the selection and appointment 
procedure laid down in point 5 of Article 1 start their term of office . 
Article 11 
Entr y into force 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 
It shall apply from 27 March 2021. 
Howe ver, points 4 and 5 of Article 1 shall apply from 1 July 2022. 6.9.2019 L 231/27 Official Jour nal of the European Union EN     This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 20 June 2019. 
For the European Parliament 
The President 
A. TAJANI  For the Council 
The President 
G. CIAMBA   6.9.2019 L 231/28 Official Jour nal of the European Union EN