Source: EURLEX
Language: en
Format: md

**EUROPEAN UNION**

**THE EUROPEAN PARLIAMENT** **THE COUNCIL**

**Brussels, 24 May 2019**
**(OR. en)**

**2018/0088 (COD)** **PE-CONS 41/19**

**AGRILEG 36**

**DENLEG 26**

**MI 149**

**SAN 81**

**CONSOM 60**

**RECH 93**

**CODEC 397**

**LEGISLATIVE ACTS AND OTHER INSTRUMENTS**

Subject: REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL on the transparency and sustainability of the EU risk
assessment in the food chain and amending Regulations
(EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003,
(EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008,
(EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC

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**REGULATION (EU) 2019/…**

**OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL**

**of …**

**on the transparency and sustainability of the EU risk assessment**

**in the food chain and amending Regulations (EC) No 178/2002,**

**(EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004,**

**(EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC**

**(Text with EEA relevance)**

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard 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 regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee **[1]**,

Having regard to the opinion of the Committee of the Regions **[2]**,

Acting in accordance with the ordinary legislative procedure **[3]**,

**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 April 2019 (not yet published in the Official
Journal) and the decision of the Council of ….

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Whereas:

(1) Regulation (EC) No 178/2002 of the European Parliament and of the Council **[1]** lays down

the general principles and requirements of food law, so as to form a common basis for

measures governing food law at both Union and national level. It provides, inter alia, that

food law is to be based on risk analysis, except where this is not appropriate 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 Safety

Authority (the "Authority"), as the responsible Union risk assessment body in matters

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' confidence in the outcome of the risk

analysis process.

**1** Regulation (EC) No 178/2002 of the European Parliament and of the Council of
28 January 2002 laying down the general principles and requirements of food law,
establishing the European Food Safety Authority and laying down procedures in matters of
food safety (OJ L 31, 1.2.2002, p. 1).

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(4) It is necessary, therefore, to ensure transparent, continuous and inclusive risk

communication throughout the risk analysis, involving Union and national risk assessors

and risk managers. Such risk communication should strengthen citizens' trust that the risk

analysis is underpinned by the objective of ensuring a high level of protection of human

health and consumers' interests. That risk communication should also be capable of

contributing to a participatory and open dialogue between all interested parties in order to

ensure that the prevalence of the public interest, and accuracy, comprehensiveness,

transparency, consistency and accountability are taken into account in the risk analysis

process.

(5) Risk communication should place particular emphasis on explaining in an accurate, clear,

comprehensive, coherent, appropriate and timely manner not only risk assessment findings

themselves but also how such findings are used to help inform risk management decisions

along with other legitimate factors, where relevant. Information should be provided on how

risk management decisions were reached and on the factors, other than the results of the

risk assessment, which 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 perception of the difference between hazard and risk,

risk communication should endeavour to clarify that distinction and thereby ensure that

such distinction is better understood by the general public.

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(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-compliance resulting from intentional violations of

applicable Union law perpetrated through fraudulent or deceptive practices, public

authorities, identifying to the fullest extent possible the products concerned and the risk

that they may present, should inform the public accordingly as soon as possible.

(8) It is necessary to establish general objectives and principles of risk communication, taking

into account the respective roles of risk assessors and managers, while guaranteeing 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 Authority and Member States, and

following relevant public consultations. That general plan should promote an integrated

risk communication framework for all risk assessors and risk managers at Union and

national level on all matters relating to the food chain. It should also allow for the

necessary flexibility and should not deal with situations specifically covered by the general

plan for crisis management.

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(10) The general plan on risk communication should identify the key factors to be taken into

account when considering the type and level of risk communication activities needed, such

as the different levels of risk, the nature of the risk and its potential impact on human

health, animal health and, where relevant, the environment, 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 perception, including the

applicable legal framework and relevant market context.

(11) The general plan on risk communication should also identify the tools and channels to be

used and should establish appropriate 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 provide scientific outputs

on the same or on related subject matters, to ensure coherent risk communication and an

open dialogue amongst all interested parties.

(12) Transparency of the risk assessment process contributes to greater legitimacy of the

Authority being acquired in the eyes of the consumers and general public in the pursuit of

its mission, increases their confidence in its work and ensures that the Authority is more

accountable to the Union citizens in a democratic system. It is therefore essential to

strengthen the confidence of the general public and other interested parties in the risk

analysis underpinning 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 Authority.

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(13) It is appropriate to increase the role of Member States as well as the effort and engagement

of all parties involved in the Management Board of the Authority (the "Management

Board").

(14) Experience shows that the role of the Management Board is focused on administrative and

financial aspects and does not impact on the independence of the scientific work performed

by the Authority. It is thus appropriate to include representatives of all Member States, of

the European Parliament and of the Commission as well as of civil society and industry

organisations in the Management Board, while providing that those representatives should

have experience and expertise not only in the fields of food chain law and policy, including

risk assessment, but also in the fields of managerial, administrative, financial and legal

matters and ensuring that they act independently in the public interest.

(15) The members of the Management Board should be selected and appointed in such a way as

to secure the highest standards of competence and the broadest range of relevant

experience available.

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(16) The Fitness Check of the General Food Law identified certain shortcomings in the long

term capability of the Authority to maintain its high-level expertise. In particular, there has

been a decrease in the number of candidates applying to be members of the Authority's

Scientific Panels. The system has thus to be strengthened and Member States should take a

more active role to ensure that a sufficient pool of experts is available to meet the needs of

the Union risk assessment system in terms of high level of scientific expertise,

independence and multidisciplinary expertise.

(17) To preserve the independence of the risk assessment from risk management and from other

interests at Union level, it is appropriate that the selection by the Authority's Executive

Director and the appointment by the Management Board of the members of the Authority's

Scientific Committee and Scientific Panels be based on strict criteria ensuring the

excellence and independence of the experts while ensuring the required multidisciplinary

expertise for each Scientific Panel. It is essential to that end that the Executive Director,

whose function is to defend the Authority's interests and in particular the independence of

its expertise, have a role in the selection of those scientific experts. The Management

Board should endeavour to ensure, to the largest extent possible, that experts appointed as

members of the Scientific Panels are scientists who are also actively conducting research,

and publishing their research findings in peer-reviewed scientific journals, provided that

they comply with the strict criteria of excellence and independence. Proper financial

compensation of the experts should be ensured. Further measures should also be put in

place to ensure that scientific experts have the means to act independently.

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(18) It is essential to ensure the efficient operation of the Authority and to improve the

sustainability of its expertise. It is therefore necessary to strengthen the support provided

by the Authority and the Member States to the work of the Scientific Committee and the

Scientific Panels. In particular, the Authority should organise the preparatory work

supporting the tasks of the Scientific Panels, including by requesting the Authority's staff

or national scientific organisations networking with the Authority to draft preparatory

scientific opinions to be peer-reviewed and adopted by those Scientific Panels. That should

be without prejudice to the independence of the Authority's scientific assessments.

(19) Authorisation procedures are based on the principle that it is for the applicant or the

notifier to prove that the subject matter of an application or notification complies with

Union requirements. That principle is based on the premise that human health, animal

health and, where relevant, the environment are better protected where the burden of proof

is on the applicant or the notifier since it has to prove that the subject matter of its

application or notification is safe prior to its placing on the market, instead of the public

authorities having to prove that that subject matter is unsafe in order to be able to ban it

from the market. In accordance with that principle and the applicable regulatory

requirements, in support of applications or notifications under Union sectoral 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 matter.

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(20) Union law provides for the content of applications and notifications. It is essential that the

application or notification submitted to the Authority for its risk assessment meet the

applicable specifications to ensure the best quality scientific assessment by the Authority.

Applicants or notifiers and in particular small and medium-sized enterprises do not always

have a clear understanding of those specifications. It is thus appropriate that, where the

Authority may be requested to provide a scientific output, it should provide 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 responsibility.

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(21) Where the Authority may be requested to provide a scientific output, it should have

knowledge of all studies performed by an applicant with a view to supporting an

application under Union law. To that end, it is necessary and appropriate that, when

business operators commission or carry out studies with a view to submitting an

application or notification, they notify those studies to the Authority. The obligation to

notify such studies should also apply to the laboratories 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 obligation, it is

appropriate to provide for certain procedural consequences in the event of non-compliance.

The Authority should, in that context, lay down practical arrangements to implement that

obligation, including procedures for requesting and making public the justifications for the

non-compliance.

(22) In accordance with Directive 2010/63/EU of the European Parliament and of the Council **[1]**,

tests on animals should be replaced, reduced or refined. Therefore, within the scope of this

Regulation, duplication of animal testing should be avoided, where possible.

**1** 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).

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(23) In the case of applications or notifications to request the renewal of an authorisation or an

approval, the authorised or approved substance or product has already been on the market

for several years. Experience and knowledge therefore already exist with regard to that

substance or product. Where the Authority may be requested to provide a scientific output,

it is appropriate for studies planned for supporting requests for renewals, including

information on the proposed design, that have been notified by the applicant or the notifier

to the Authority, to be submitted for consultation of third parties. The Authority should

systematically provide advice to the applicants or to the notifiers on the content of the

intended renewal application or notifications, as well as on the design of studies, taking

into account the comments received.

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(24) There are certain public concerns about the Authority's assessment in the area of

authorisation procedures being primarily based on industry studies. It is of utmost

importance that the Authority carry out searches in scientific literature to be able to

consider other data and studies existing on the subject matter submitted to its assessment.

In order to provide an additional level of guarantee to ensure that the Authority can have

access to all relevant scientific data and studies available on a subject matter of an

application or a notification for an authorisation or a renewal of an authorisation or an

approval, it is appropriate to provide for consultation of third parties in order to identify

whether other relevant scientific data or studies are available. To increase the effectiveness

of the consultation, the consultation should take place immediately after the studies

submitted by industry 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

appropriate to provide for a limited extension of those deadlines.

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(25) Food safety is a sensitive matter of prime interest for all Union citizens. While maintaining

the principle that the burden to prove compliance with Union requirements is on the

industry, it is important to establish an additional verification tool, namely the

commissioning of additional studies with the objective of verifying evidence used in the

context of risk assessment to address specific cases of high societal importance where there

are serious controversies or conflicting results. Considering that those verification studies

would be financed from the Union budget and that the use of this exceptional verification

tool should remain proportionate, 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 taken 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 Authority has

made considerable progress in terms of transparency, the risk assessment process,

especially in the context of authorisation procedures covering the food chain, is not always

perceived as fully transparent. That is also partly due to the different transparency and

confidentiality rules that are laid down in Regulation (EC) No 178/2002 and in other Union

sectoral legislative acts. The interplay among those acts can have an impact on the

acceptance of the risk assessment by the general public.

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(27) The European citizens' initiative entitled "Ban glyphosate and protect people and the

environment from toxic pesticides" further confirmed concerns regarding transparency

with respect to studies commissioned by the industry and submitted in authorisation

procedures.

(28) It is therefore necessary to strengthen the transparency of the risk assessment in a proactive

manner. All scientific data and information supporting requests for authorisations 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 concerning intellectual property rights or to any provisions of Union

law protecting the investment made by innovators in gathering the information and data

supporting relevant applications or notifications. 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 summary of the pre-submission advice

should be made public only once a corresponding application or notification has been

made public in accordance with the applicable rules on transparency.

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(30) Where the opinion of the Authority is requested in relation to applications or notifications

submitted under Union law, and having regard to its obligation to ensure public access to

all supporting information with respect to the provision of its scientific outputs, the

Authority should have responsibility for assessing confidentiality requests.

(31) To determine what level of proactive disclosure to the public strikes the appropriate

balance, the relevant rights of the public to transparency in the risk assessment process,

should be weighed up against the rights of applicants or notifiers, taking into account the

objectives of Regulation (EC) No 178/2002.

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(32) With respect to the application or notification procedures provided for in Union law,

experience gained so far has shown that certain items of information are generally

considered sensitive and should remain confidential across the different sectoral

procedures. It is therefore appropriate 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 potentially harm the commercial interests concerned to a significant

degree and which should not therefore be disclosed to the public. Those items should

include the manufacturing and production process, including the method and innovative

aspects thereof, as well as technical and industrial specifications, such as impurities,

inherent to that process other than information which is relevant to the assessment of

safety. Only in very limited and exceptional circumstances relating to foreseeable health

effects or, where an environmental assessment is required under Union sectoral law, to

environmental effects, or where relevant authorities have identified urgent needs to protect

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 necessary to set out the

specific procedural requirements to be followed by an applicant or by a notifier in respect

of a request for information submitted to support an application or a notification under

Union law to be treated in a confidential manner.

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(34) It is also necessary to set out specific requirements with respect to the protection and

confidentiality of personal data for the purposes of the transparency of the risk assessment

process, taking into account Regulations (EU) 2018/1725 **[1]** and (EU) 2016/679 **[2]** of the

European Parliament and of the Council. Accordingly, no personal data should be made

publicly available under this Regulation, unless it is necessary and proportionate for the

purposes of ensuring the transparency, independence and the reliability of the risk

assessment process, while preventing conflicts of interests. In particular, for the purpose of

ensuring the transparency and to avoid conflicts of interest, it is necessary to publish the

names of the participants and observers in certain meetings of the Authority.

(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.

**1** Regulation (EU) 2018/1725 of the European Parliament and of the Council of
23 October 2018 on the protection of natural persons with regard 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).
**2** Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 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).

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(36) Having regard to the fact that the Authority would be required to store scientific data,

including confidential and personal data, it is necessary to ensure that such storage is

carried out in accordance with a high level of security.

(37) Furthermore, in order to assess the effectiveness and efficiency of the different legal

provisions applicable to the Authority, it is also appropriate to provide for a Commission

evaluation of the Authority. That evaluation should, in particular, review the procedures

for selecting the members of Scientific Committee and Scientific Panels, for their degree of

transparency, cost-effectiveness, and suitability to ensure independence and competence,

and to prevent conflicts of interests.

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(38) Studies, including tests, submitted by business operators in support of applications usually

comply with internationally recognised principles, which provide a uniform basis for their

quality in particular in terms of reproducibility of results. However, issues of compliance

with the applicable standards, such as those set by Directive 2004/10/EC of the European

Parliament and of the Council **[1]** or those developed by the International Organization for

Standardization, may arise in some cases and this is why international and national systems

are in place to verify such compliance. It is therefore appropriate 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

Authority as part of an application. Those fact-finding missions would allow the

Commission to identify, and to aim at correcting, possible weaknesses in the systems and

non-compliance and to provide an additional level of guarantees to reassure the general

public on the quality of studies. Based on the conclusions of such fact-finding missions, the

Commission could propose appropriate legislative measures aimed at improving

compliance with the relevant standards.

**1** Directive 2004/10/EC of the European Parliament and of the Council of 11 February 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).

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(39) In order to ensure consistency with the proposed adaptations in Regulation (EC)

No 178/2002, provisions relating to public access and the protection of confidential

information in, Regulations (EC) No 1829/2003 **[1]**, (EC) No 1831/2003 **[2]**,

(EC) No 2065/2003 **[3]**, (EC) No 1935/2004 **[4]**, (EC) No 1331/2008 **[5]**, (EC) No 1107/2009 **[6]**,

(EU) 2015/2283 **[7]** and in Directive 2001/18/EC **[8]** of the European Parliament and of the

Council should be amended.

**1** Regulation (EC) No 1829/2003 of the European Parliament and of the Council of
22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1).
**2** Regulation (EC) No 1831/2003 of the European Parliament and of the Council of
22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29).
**3** Regulation (EC) No 2065/2003 of the European Parliament and of the Council of
10 November 2003 on smoke flavourings used or intended for use in or on foods (OJ L 309,
26.11.2003, p. 1).
**4** Regulation (EC) No 1935/2004 of the European Parliament and of the Council of
27 October 2004 on materials 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).
**5** Regulation (EC) No 1331/2008 of the European Parliament and of the Council of
16 December 2008 establishing a common authorisation procedure for food additives, food
enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1).
**6** Regulation (EC) No 1107/2009 of the European Parliament and of the Council of
21 October 2009 concerning the placing of plant protection products on the market and
repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).
**7** 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).
**8** 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).

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(40) To ensure that sectoral specificities with respect to confidential information are taken into

account, it is necessary to weigh up the relevant rights of the public to transparency in the

risk assessment process against the rights of applicants or of notifiers, taking into account

the specific objectives of sectoral Union law as well as experience gained. Accordingly, it

is necessary 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.

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(41) The rights on access to documents enshrined in Regulation (EC) No 1049/2001 of the

European Parliament and of the Council **[1]** and, where environmental information is

concerned, the rights enshrined in Regulation (EC) No 1367/2006 **[2]** and Directive

2003/4/EC **[3]** of the European Parliament and of the Council are unaffected by this

Regulation. The rights provided by those acts should not in any manner be limited by the

provisions on proactive dissemination laid down in this Regulation and the relevant

assessment of confidentiality request.

**1** 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).
**2** Regulation (EC) No 1367/2006 of the European Parliament and of the Council of
6 September 2006 on the application of the provisions 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).
**3** Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on
public access to environmental information and repealing Council Directive 90/313/EEC
(OJ L 41, 14.2.2003, p. 26).

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(42) In order to ensure uniform conditions for the implementation of Regulation (EC)

No 178/2002 with regard to the adoption of a general plan for risk communication and the

adoption of standard data formats, implementing powers should be conferred on the

Commission. Those powers should be exercised in accordance with Regulation (EU)

No 182/2011 of the European Parliament and of the Council **[1]** .

(43) In order to enable the Commission, Member States, the Authority and the business

operators to adapt to the new requirements set by this Regulation while ensuring that the

Authority continues its smooth operation, it is necessary to provide for transitional

measures for the application of this Regulation.

(44) Since the appointment of the members of the Scientific Committee and Scientific Panels

depends on the entry in function of the new Management Board, it is necessary to provide

for specific transitional provisions allowing a prolongation of the current term of office of

the members of the Scientific Committee and Scientific Panels.

**1** Regulation (EU) No 182/2011 of the European Parliament and of the Council of
16 February 2011 laying down the rules and general principles concerning mechanisms for
control by Member States of the Commission's exercise of implementing powers (OJ L 55,
28.2.2011, p. 13).

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(45) The European Data Protection Supervisor was consulted in accordance with Article 28(2)

of Regulation (EC) No 45/2001 of the European Parliament and of the Council **[1]**,

HAVE ADOPTED THIS REGULATION:

**1** Regulation (EC) No 45/2001 of the European Parliament and of the Council of
18 December 2000 on the protection of individuals with regard 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).

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_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 Chapter II, the following Section is inserted:

"S ECTION 1a

R ISK COMMUNICATION

_Article 8a_

_Objectives of risk communication_

Taking into account the respective roles of risk assessors and risk managers, risk

communication shall pursue the following objectives:

(a) raise awareness and understanding of the specific issues under consideration,

including in cases of divergences in scientific assessment, during the entire risk

analysis process;

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(b) ensure consistency, transparency and clarity in formulating risk management

recommendations and decisions;

(c) provide a sound basis, including, where appropriate, a scientific basis, for

understanding risk management 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 managers to enhance confidence in its

outcome;

(f) ensure appropriate involvement of consumers, feed and food businesses, the

academic community and all other interested parties;

(g) ensure appropriate 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 strategies;

and

(i) contribute to the fight against the dissemination of false information and the sources

thereof.

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_Article 8b_

_General principles of risk communication_

Taking into account the respective roles of risk assessors and risk managers, risk

communication shall:

(a) ensure that accurate and all appropriate information is exchanged in an interactive

and timely manner with all interested parties, based on the principles of transparency,

openness, and responsiveness;

(b) provide 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

adoption of risk management decisions, including information on how risk

management decisions were reached and which factors were considered;

(c) take into account risk perceptions of all interested parties;

(d) facilitate understanding and dialogue amongst all interested parties; and

(e) be clear and accessible, including to those not directly involved in the process or not

having a scientific background, while duly respecting the applicable legal provisions

on confidentiality and protection of personal data.

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_Article 8c_

_General plan for risk communication_

1. The Commission shall adopt, by means of implementing 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 updated, taking into account technical and scientific progress and

experience gained. Those implementing acts shall be adopted in accordance with the

procedure referred to in Article 58(2). When preparing those implementing acts, the

Commission shall consult the Authority.

2. The general plan for risk communication shall promote an integrated risk

communication framework to be followed both by the risk assessors and the risk

managers in a coherent and systematic manner both at Union and national level. It

shall:

(a) identify the key factors that need to be taken into account when considering the

type and level of risk communication activities needed;

(b) identify the different types and levels of risk communication activities, and the

appropriate main tools and channels to be used for risk communication

purposes, taking into account the needs of relevant target audience groups;

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(c) establish appropriate mechanisms of coordination and cooperation in order to

strengthen coherence of risk communication amongst risk assessors and risk

managers; and

(d) establish appropriate mechanisms to ensure an open dialogue amongst

consumers, food and feed businesses, the academic community and all other

interested parties, and their appropriate involvement.";

(3) in Article 22(7), the second subparagraph is replaced by the following:

"It shall act in close cooperation with the competent bodies in the Member States that carry

out similar tasks to those of the Authority and, where appropriate, 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 Management Board. The members and alternate

members thus nominated shall be appointed by the Council and have the right

to vote.";

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(b) the following paragraphs are inserted:

"1a. In addition to members and alternate members referred to in paragraph 1, the

Management Board shall include:

(a) two members and two alternate 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 interests, namely one

member and one alternate member from consumer organisations, one

member and one alternate member from environmental non

governmental organisations, one member and one alternate member from

farmers organisations, and one member and one alternate member from

industry organisations.

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The members and alternate 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 which 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 background documents. As quickly as possible and at the latest within

three months of the receipt 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 alternate members of the Management Board shall be

nominated and appointed on the basis of their relevant experience and expertise

in the field of food chain law and policy, including risk assessment, whilst

ensuring that there is relevant expertise in the fields of managerial,

administrative, financial and legal matters within the Management Board.";

(c) paragraph 2 is replaced by the following:

"2. The term of office of members and alternate members shall be four years and

may be renewed. However, the term of office of the members and alternate

members referred to in point (c) of the first subparagraph of paragraph 1a may

be renewed only once.";

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(d) in paragraph 5, the second subparagraph is replaced by the following:

"Unless otherwise provided, the Management Board shall act by a majority of its

members. Alternate 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

Scientific Panels and the members of the Scientific Panels shall be appointed

by the Management Board, acting upon a proposal from the Executive

Director, 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 Authority shall publish such a call for expression of

interest after having informed the Member States about the necessary criteria

and fields of expertise.

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The Member States shall:

(a) publish the call for expression of interest on the websites of their

competent authorities and of their competent bodies which undertake

tasks similar to those of the Authority;

(b) inform relevant scientific organisations located on their territory;

(c) encourage potential candidates to apply; and

(d) take any other appropriate measures to support the call for expression of

interest.";

(b) the following paragraphs are inserted:

"5a. The members of the Scientific Committee who are not members of Scientific

Panels and the members of the Scientific Panels shall be selected 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 Director shall draw up a draft list of suitable

candidates including at least twice the number of candidates necessary to

fill the posts in the Scientific Committee and the Scientific Panels and

send the draft list to the Management Board, indicating the specific

multidisciplinary expertise needed in each Scientific Panel;

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(b) on the basis of that draft list, the Management Board shall appoint the

members of the Scientific Committee who are not members of the

Scientific Panels and the members of the Scientific Panels and draw up

the reserve list of candidates for the scientific Committee and the

Scientific Panels;

(c) the selection procedure and the appointments of the members of the

Scientific Committee who are not members of the Scientific Panels and

the members of the Scientific Panels shall be made on the basis of the

following criteria:

(i) a high level of scientific expertise;

(ii) independence and absence of conflict of interests in accordance

with Article 37(2) and the Authority's independence policy and

implementation of that policy in respect of the members of the

Scientific Panels;

(iii) meeting the needs for the specific multi-disciplinary expertise of

the Scientific Panel to which they will be appointed and the

applicable language regime;

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(d) where candidates have equivalent scientific expertise, the Management

Board shall ensure that the broadest possible geographical distribution is

achieved in the appointments.

5b. When the Authority identifies that specific expertise is missing in one or

several Scientific Panels, the Executive Director shall propose to the

Management 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 Management Board shall adopt, on the basis of a proposal of the Executive

Director, rules on the detailed organisation and timing of the procedures set up

in paragraphs 5a and 5b.

5d. Member States and employers of the members of the Scientific Committee and

of the Scientific Panels shall refrain from giving those members, or the external

experts participating in the working groups of the Scientific Committee or the

Scientific Panels, any instruction which is incompatible with the individual

tasks of those members and experts, or with the tasks, responsibilities and

independence of the Authority.

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5e. The Authority shall support the tasks of the Scientific Committee and

Scientific Panels by organising their work, in particular the preparatory work to

be undertaken by the Authority's staff or by designated national scientific

organisations referred to in Article 36, including by organising the possibility

for preparing scientific opinions to be peer-reviewed by the Scientific 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 following:

"(b) the number of members in each Scientific Panel but no more than the

maximum number provided for in paragraph 5f.";

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(6) the following Articles are inserted:

" _Article 32a_

_Pre-submission advice_

1. Where Union law contains provisions for the Authority to provide a scientific output,

including a scientific opinion, the staff of the Authority shall, at the request of a

potential applicant or notifier, provide advice on the rules applicable to, and the

content required for, the application or notification, prior to its submission. Such

advice provided by the staff of the Authority shall be without prejudice and non

committal as to any subsequent assessment of applications or notifications by the

Scientific Panels. The staff of the Authority providing the advice shall not be

involved in any preparatory scientific or technical work that is directly or indirectly

relevant to the application or notification that is the subject of the advice.

2. The Authority shall publish general guidance on its website regarding the rules

applicable to, and the content required for, applications and notifications, including,

where appropriate, general guidance on the design of required studies.

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_Article 32b_

_Notification of studies_

1. The Authority shall establish and manage a database of studies commissioned or

carried out by business operators to support an application or notification in relation

to which Union law contains provisions for the Authority to provide a scientific

output, including a scientific opinion.

2. For the purposes of paragraph 1, business operators shall, without delay, notify the

Authority of the title and the scope of any study commissioned or carried out by

them to support an application or a notification, as well as the laboratory or testing

facility carrying out that study, and its starting and planned completion dates.

3. For the purposes of paragraph 1, laboratories and other testing facilities located in the

Union shall also, without delay, notify the Authority of the title and the scope of any

study commissioned by business operators and carried out by such laboratories or

other testing facilities to support an application or a notification, its starting and

planned completion dates, as well as the name of the business operator who

commissioned such a study.

This paragraph shall also apply, mutatis mutandis, to laboratories and other testing

facilities located in third countries insofar as set out in relevant agreements and

arrangements with those third countries, including as referred to in Article 49.

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4. An application or notification shall not be considered valid or admissible where it is

supported by studies that have not been previously notified in accordance with

paragraph 2 or 3, unless the applicant or notifier provides a valid justification for the

non-notification of such studies.

Where studies have not been previously notified in accordance with paragraph 2 or 3,

and where a valid justification has not been provided, an application or notification

may be re-submitted, provided that the applicant or notifier notifies to the Authority

those studies, in particular their title and their scope, the laboratory or testing facility

carrying them out as well as their starting and planned completion dates.

The assessment of the validity or the admissibility of such re-submitted application

or notification shall commence six months after the notification of the studies

pursuant to the second subparagraph.

5. An application or notification 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 notification, unless the applicant or notifier

provides a valid justification for the non-inclusion of such studies.

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Where the studies which have previously been notified in accordance with

paragraph 2 or 3 were not included in the application or notification, and where a

valid justification has not been provided, an application or notification may be

resubmitted, 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-submitted application or

notification shall commence six months after the submission of the studies pursuant

to the second subparagraph.

6. Where the Authority detects, during its risk assessment, that studies notified in

accordance with paragraph 2 or 3 are not included in the corresponding application

or notification in full, and in the absence of a valid justification of the applicant or

notifier to that effect, the applicable time limits within which the Authority 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 Authority shall make public the notified information only in cases where it

received a corresponding application or notification and after the Authority has

decided on the disclosure of the accompanying studies in accordance with

Articles 38 to 39e.

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8. The Authority shall lay down the practical arrangements for implementing the

provisions of this Article, including arrangements for requesting and making public

the valid justifications in the cases referred to in paragraphs 4, 5 and 6. Those

arrangements 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 approval or an authorisation,

including by means of a notification, may be renewed, the potential applicant or

notifier for the renewal shall notify the Authority of the studies it intends to perform

for that purpose, including information on how the various studies are to be carried

out to ensure compliance with regulatory requirements. Following such notification

of studies, the Authority shall launch 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 which are

relevant for the risk assessment of the intended renewal, the Authority shall provide

advice on the content of the intended renewal application or notification, as well as

on the design of the studies. The advice provided by the Authority shall be without

prejudice and non-committal as to the subsequent assessment of the applications or

notifications for renewal by the Scientific Panels.

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2. The Authority shall consult stakeholders and the public on the basis of the non

confidential version of the application or notification made public by the Authority in

accordance with Articles 38 to 39e, and immediately after such disclosure to the

public, in order to identify whether other relevant scientific data or studies are

available on the subject matter concerned by the application or notification. In duly

justified cases, where there is a risk that the results of the public consultation

performed in accordance with this paragraph cannot be given proper consideration

because of the applicable time limits within which the Authority is required to

deliver its scientific output, those time limits may be extended for a maximum period

of seven weeks. This paragraph is without prejudice to the Authority's obligations

under Article 33 and does not apply to the submission of any supplementary

information by the applicants or notifiers during the risk assessment process.

3. The Authority shall lay down the practical arrangements for implementing the

procedures referred to in this Article and Article 32a.

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_Article 32d_

_Verification studies_

Without prejudice to the obligation on applicants to demonstrate the safety of a subject

matter submitted to a system of authorisation, the Commission, in exceptional

circumstances of serious controversies or conflicting results, may request the Authority to

commission scientific 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 Authority shall carry out its activities with a high level of transparency. It

shall in particular make public:

(a) agendas, participant lists and minutes of the Management Board, the

Advisory Forum, the Scientific Committee and the Scientific Panels and

their working groups;

(b) all its scientific outputs, including the opinions of the Scientific

Committee and the Scientific Panels after adoption, minority opinions

and results of consultations performed during the risk assessment process

always being included;

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(c) scientific data, studies and other information supporting applications,

including supplementary information supplied by applicants, as well as

other scientific data and information supporting requests from the

European Parliament, the Commission and the Member States for a

scientific output, including a scientific opinion, taking into account the

protection of confidential 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 confidential

information and the protection of personal data in accordance with

Articles 39 to 39e;

(e) the annual declarations of interest made by the members of the

Management Board, the Executive Director and the members of the

Advisory Forum, the Scientific Committee and the Scientific Panels, as

well as the members of the working groups, and the declarations of

interest made in relation to items on the agendas of meetings;

(f) its scientific studies in accordance with Articles 32 and 32d;

(g) the annual report of its activities;

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(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 justifications for the refusal or modification;

(i) a summary of the advice provided to potential applicants at pre

submission phase pursuant to Articles 32a and 32c.

Information referred to in the first subparagraph shall be made public without

delay, with the exception of the information referred to in point (c) thereof, as

far as applications are concerned, and in point (i) thereof, which shall be made

public without delay once an application has been considered valid or

admissible.

The information referred to in the second subparagraph shall be made public in

a dedicated section of the Authority's website. That dedicated section shall be

publicly available and easily accessible. That information shall be available to

be downloaded, printed and searched through in an electronic format.";

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(b) the following paragraph is inserted:

"1a. The disclosure of the information referred 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 concerning intellectual property rights which set out

limitations on certain uses of the disclosed documents or their content;

and

(b) any provisions set out in Union law protecting the investment made by

innovators in gathering the information and data supporting relevant

applications for authorisations ('data exclusivity rules').

The disclosure to the public of the information referred 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

content to be used, reproduced, or otherwise exploited in breach of any

intellectual property right or data exclusivity rules, and the Union shall not be

responsible for its use by third parties. The Authority shall ensure that clear

undertakings or signed statements are given to that effect by those who access

the relevant information prior to its disclosure.";

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(c) paragraph 3 is replaced by the following:

"3. The Authority shall lay down the practical arrangements 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 following:

" _Article 39_

_Confidentiality_

1. By way of derogation from Article 38, the Authority shall not make public any

information for which confidential treatment has been requested under the conditions

laid down in this Article.

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 demonstrated by the applicant to potentially harm its interests to a

significant degree:

(a) the manufacturing or production process, including the method and innovative

aspects thereof, as well as other technical and industrial specifications inherent

to that process or method, except for information which is relevant to the

assessment of safety;

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(b) commercial links between a producer or importer and the applicant or the

authorisation holder, where applicable;

(c) commercial information revealing sourcing, market shares or business strategy

of the applicant; and

(d) quantitative composition of the subject matter of the request, except for

information which 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 emergency situations, the Authority may disclose the

information referred to in paragraphs 2 and 3;

(b) information which forms part of conclusions of scientific outputs, including

scientific opinions, delivered by the Authority and which relate to foreseeable

effects on human health, animal health or the environment, shall nevertheless

be made public.";

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(9) the following Articles are inserted:

" _Article 39a_

_Confidentiality request_

1. When submitting an application, supporting scientific data and other supplementary

information in accordance with Union law, the applicant may request certain parts of

the information submitted to be treated as confidential in accordance with Article

39(2) and (3). Such request shall be accompanied by verifiable justification that

demonstrates how making public the information concerned significantly harms the

interests concerned in accordance with Article 39(2) and (3).

2. Where an applicant submits a request for confidentiality, it shall provide a non

confidential version and a confidential 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 deleted. The confidential version shall contain all

information submitted, including information the applicant deems confidential.

Information requested to be treated as confidential in the confidential version shall be

clearly marked. The applicant shall clearly indicate the grounds on the basis of which

confidentiality is requested for the different pieces of information.

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_Article 39b_

_Decision on confidentiality_

1. The Authority shall:

(a) make public the non-confidential version of the application as submitted by the

applicant without delay once that application has been considered valid or

admissible;

(b) proceed, without delay, 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 Authority formally takes a decision on the

confidentiality request. If the applicant disagrees with the assessment of the

Authority, the applicant may state its views or withdraw its application within

two weeks of the date on which it was notified of the Authority's position;

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(d) adopt a reasoned decision on the confidentiality request, taking into account the

observations of the applicant, within 10 weeks of the date of receipt of the

confidentiality request with respect to applications and without delay in the

case of supplementary data and information; notify the applicant of its decision

and provide information on the right to submit a confirmatory application in

accordance with paragraph 2;, and inform the Commission and the Member

States, where appropriate, of its decision; and

(e) make public any additional data and information for which the confidentiality

request has not been accepted as justified at the earliest two weeks after the

notification of its decision to the applicant has taken place pursuant to

point (d).

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2. Within two weeks of the notification of the Authority's decision on the

confidentiality request to the applicant pursuant to paragraph 1, the applicant may

submit a confirmatory application asking the Authority to reconsider its decision.

The confirmatory application shall have suspensive effect. The Authority shall

examine the grounds for the confirmatory application and shall adopt a reasoned

decision on that confirmatory application. It shall notify the applicant of that decision

within three weeks of submitting the confirmatory application and shall include in

that notification information on the available remedies, namely an action before the

Court of Justice of the European Union (the 'Court of Justice') against the Authority

pursuant to paragraph 3. The Authority shall make public any additional data and

information for which the confidentiality request has not been accepted by the

Authority as justified, at the earliest two weeks after the notification of the

Authority's reasoned decision on the confirmatory application to the applicant has

taken place pursuant to this paragraph.

3. Decisions taken by the Authority pursuant to this Article may be subject to an action

before the Court of Justice, under the conditions laid down in Articles 263 and 278 of

the Treaty on the Functioning of the European Union (TFEU) respectively.

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_Article 39c_

_Review of confidentiality_

Before the Authority issues its scientific outputs, including scientific opinions, it shall

review whether information that has been previously accepted as confidential may

nevertheless be made public in accordance with point (b) of Article 39(4). Should that be

the case, the Authority shall follow the procedure laid down in Article 39b, which shall

apply mutatis mutandis.

_Article 39d_

_Obligations with regard to confidentiality_

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 scientific output, including a scientific opinion, unless otherwise indicated in Union

law.

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2. The Commission and the Member States shall take the necessary measures so that

information received by them under Union law for which confidential treatment has

been requested is not made public until a decision on the confidentiality request has

been taken by the Authority and has become final. The Commission and the Member

States shall also take the necessary measures so that information for which

confidential treatment has been accepted by the Authority is not made public.

3. If an applicant withdraws or has withdrawn an application, the Authority, the

Commission and the Member States shall respect the confidentiality of information

as granted by the Authority in accordance with Articles 39 to 39e. The application

shall be considered withdrawn as of the moment the written request to that effect is

received by the competent body that had received the original application. Where the

withdrawal of the application takes place before a final decision on the

confidentiality request has been adopted by the Authority pursuant to, where

appropriate, Article 39b(1) or (2), the Commission, the Member States and the

Authority, shall not make public the information for which confidentiality has been

requested.

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4. Members of the Management Board, the Executive Director, members of the

Scientific Committee and Scientific Panels as well as external experts participating in

their working groups, members of the Advisory Forum and members of the staff of

the Authority, 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 Authority shall lay down in consultation with the Commission the practical

arrangements for implementing the confidentiality rules laid down in Articles 39,

39a, 39b, 39e and in this Article, including arrangements concerning the submission

and treatment of confidentiality 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 Authority shall ensure that appropriate separation of tasks is

applied for the assessment of confirmatory applications.

_Article 39e_

_Protection of personal data_

1. With respect to requests for scientific outputs, including scientific opinions under

Union law, the Authority shall always make public:

(a) the name and address of the applicant;

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(b) the names of authors of published or publicly available studies supporting such

requests; and

(c) the names of all participants and observers in meetings of the Scientific

Committee and the Scientific Panels, their working groups and any other ad

hoc group meeting on the subject matter.

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 otherwise specified 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.

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_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 Authority for a scientific output, standard data formats

shall be adopted in accordance with paragraph 2 of this Article to allow documents to

be submitted, searched, copied and printed, while ensuring compliance with

regulatory requirements set out in Union law. Those standard data formats shall:

(a) not be based on proprietary standards;

(b) ensure interoperability with existing data submission approaches to the extent

possible;

(c) be user-friendly and adapted for the use by small and medium-sized

enterprises.

2. For the adoption of standard data formats referred to in paragraph 1, the following

procedure shall be followed:

(a) the Authority shall draw up draft standard data formats for the purposes of the

different authorisation procedures and relevant requests for a scientific output

by the European Parliament, by the Commission and by the Member States;

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(b) the Commission shall, taking into account the applicable requirements in the

different authorisation procedures and other legal frameworks and following

any necessary adaptations, adopt, by means of implementing acts, standard

data formats. Those implementing acts shall be adopted in accordance with the

procedure referred to in Article 58(2);

(c) the Authority shall make the standard data formats, as adopted, available on its

website;

(d) where standard data formats have been adopted pursuant to this Article,

applications as well as requests for a scientific output, including a scientific

opinion by the European Parliament, by the Commission and by the Member

States, shall only be submitted in accordance with those standard data formats.

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_Article 39g_

_Information systems_

The information systems operated by the Authority to store its data, including confidential

and personal data shall be designed in a way that guarantees that any access to it is fully

auditable and that the highest standards of security appropriate to the security 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 April 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 protection of natural persons with regard 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).";

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(10) in Article 40(3), the second subparagraph is replaced by the following:

"The Authority shall make public all scientific outputs including the scientific opinions

issued by it and supporting 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 confidentiality provided 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 Authority.

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Where environmental information is concerned, 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 States,

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 September 2006 on the application of the provisions 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).
******* Directive 2003/4/EC of the European Parliament and of the Council of
28 January 2003 on public access to environmental information and repealing
Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26).";

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(b) paragraph 2 is replaced by the following:

"2. The Management 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 …  six months after the date of entry into

force of this amending Regulation , ensuring as wide access as possible to

documents in its possession.";

(12) Article 61 is replaced by the following:

" _Article 61_

_Review clause_

1. The Commission shall ensure the regular review of the application of this

Regulation.

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2. By …  five years after the date of application of this amending Regulation , and

every five years thereafter, the Commission shall evaluate the Authority's

performance in relation to its objectives, mandate, tasks, procedures and location, in

accordance with Commission guidelines. That evaluation shall also cover the impact

of Article 32a on the functioning of the Authority with particular attention to the

relevant workload and mobilisation of staff, and to any shifts in the allocation of the

Authority's resources that may have taken 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.

3. In the evaluation referred to in paragraph 2, the Commission shall also evaluate

whether the organisational framework of the Authority needs to be further updated

with regard to decisions on requests for confidentiality and confirmatory

applications, namely by setting up a specific Board of Appeal or by other appropriate

means.

4. Where the Commission considers that the continued operation of the Authority is no

longer justified with regard to its assigned objectives, mandate and tasks, it may

propose that the relevant provisions of this Regulation be amended accordingly or

repealed.

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5. The Commission shall report to the European Parliament, to the Council and to the

Management Board on the findings of its reviews and evaluations under this Article.

Those findings shall be made public.";

(13) the following Article is inserted:

" _Article 61a_

_Fact-finding missions_

Commission experts 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 submitted to the Authority as part of an application, as well

as compliance with the notification obligation set out in Article 32b(3), by …  four years

after the date of application of this amending Regulation  . By that date, Commission

experts shall also perform fact-finding missions to assess the application of those standards

by laboratories and other testing facilities located in third countries insofar as set out in

relevant agreements and arrangements with those third countries, including as referred to

in Article 49.

Non-compliance identified during those fact-finding missions shall be brought to the

attention of the Commission, Member States, the Authority as well as the assessed

laboratories and other testing facilities. The Commission, the Authority and Member States

shall ensure the appropriate follow-up to such identified non-compliance.

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The outcome of these fact-finding missions shall be presented in an overview report. On

the basis of that report, the Commission shall submit a legislative proposal, if appropriate,

as regards, in particular, any necessary control procedures, including audits.".

_Article 2_

_Amendments to Regulation (EC) No 1829/2003_

Regulation (EC) No 1829/2003 is amended as follows:

(1) in Article 5, paragraph 3 is amended as follows:

(a) the introductory wording is replaced by the following:

"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 following:";

(b) point (l) is replaced by the following:

"(l) an identification of the parts of the application and any other supplementary

information that the applicant requests to be treated as confidential,

accompanied by verifiable justification, pursuant to Article 30 of this

Regulation and Article 39 of Regulation (EC) No 178/2002;";

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(c) the following point is added:

"(m) a summary of the dossier in a standardised form.";

(2) in Article 6, paragraph 7 is replaced by the following:

"7. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002,

shall make 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.";

(3) in Article 10, paragraph 1 is replaced by the following:

"1. On its own initiative or following a request from the Commission or from a

Member State, the Authority shall issue an opinion on whether an authorisation for a

product referred 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 authorisation-holder. The Authority, in accordance with

Article 38(1) of Regulation (EC) No 178/2002, shall make 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.";

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(4) in Article 11(2), the introductory wording is replaced by the following:

"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 introductory wording is replaced by the following:

"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:";

(b) point (l) is replaced by the following:

"(l) an identification of the parts of the application and any other supplementary

information that the applicant requests to be treated as confidential,

accompanied by verifiable justification, pursuant to Article 30 of this

Regulation and Articles 39 to 39e of Regulation (EC) No 178/2002;";

(c) the following point is added:

"(m) a summary of the dossier in a standardised form.";

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(6) in Article 18, paragraph 7 is replaced by the following:

"7. The Authority shall, in accordance with Article 38(1) of Regulation

(EC) No 178/2002, make its opinion public, after the 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.";

(7) in Article 22, paragraph 1 is replaced by the following:

"1. On its own initiative or following a request from the Commission or from a Member

State, the Authority shall issue an opinion on whether an authorisation 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

authorisation-holder. The Authority, in accordance with Article 38(1) of Regulation

(EC) No 178/2002, shall make its opinion public, after deletion of any information

identified as confidential in accordance with Articles 39 to 39eof 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.";

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(8) in Article 23(2), the introductory wording is replaced by the following:

"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 following:

"1. The Authority shall make public the application for authorisation, relevant

supporting information and any supplementary information supplied by the

applicant, as well as its scientific opinions and opinions from the competent

authorities referred 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 Authority shall apply 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 **[*]** 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).";

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(10) Article 30 is replaced by the following:

" _Article 30_

_Confidentiality_

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, accompanied by verifiable

justification; and

(b) the Authority shall assess the confidentiality request submitted by the

applicant.

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 Authority may also grant confidential treatment with respect to the following

information, where the disclosure of such information is demonstrated by the

applicant to potentially harm its interests to a significant degree:

(a) DNA sequence information, except for sequences used for the purpose of

detection, identification and quantification of the transformation event; and

(b) breeding patterns and strategies.

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3. The use of the detection methods and the reproduction of the reference materials,

provided under Articles 5(3) and 17(3) for the purpose of applying this Regulation to

GMOs, food or feed to which an application refers, shall not be restricted by the

exercise of intellectual property rights or otherwise.

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 follows:

(1) Article 7 is amended as follows:

(a) paragraph 1 is replaced by the following:

"1. An application for an authorisation 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, which shall apply mutatis mutandis. The Commission shall

without delay inform the Member States and forward the application to the

European Food Safety Authority (hereinafter referred to as the 'Authority').";

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(b) in paragraph 2, point (c) is replaced by the following:

"(c) make public the application and any information supplied by the applicant, in

accordance with Article 18.";

(2) Article 18 is replaced by the following:

" _Article 18_

_Transparency and confidentiality_

1. The Authority shall make public the application for authorisation, relevant

supporting information and any supplementary information supplied by the

applicant, as well as its scientific 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 justification. The Authority shall assess the

confidentiality request submitted by the applicant.

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3. In addition to the items of information referred to in Article 39(2) of Regulation (EC)

No 178/2002 and pursuant to Article 39(3) thereof, the Authority may also grant

confidential treatment with respect to the following items of information, where the

disclosure of such information is demonstrated by the applicant to potentially harm

its interests to a significant degree:

(a) the study plan for studies demonstrating the efficacy of a feed additive in terms

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 impurities of the active substance and the relevant

methods of analysis developed internally by the applicant, except for impurities

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.".

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_Article 4_

_Amendments to Regulation (EC) No 2065/2003_

Regulation (EC) No 2065/2003 is amended as follows:

(1) Article 7 is amended as follows:

(a) in paragraph 2, point (c) is replaced by the following:

"(c) The Authority shall:

(i) inform without delay the Commission and the other Member States of the

application and shall make the application and any supplementary

information supplied by the applicant available to them; and

(ii) make public the application, relevant supporting information and any

supplementary information supplied by the applicant, in accordance with

Articles 14 and 15.";

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(b) paragraph 4 is replaced by the following:

"4. The Authority shall publish detailed guidance, following the agreement with

the Commission, concerning the preparation and the submission of the

application, referred 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 following:

"1. The Authority shall make public the application for authorisation, relevant

supporting information and any supplementary information supplied by the applicant

as well as its scientific opinions, in accordance with Articles 38 to 39e of Regulation

(EC) No 178/2002.";

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(3) Article 15 is replaced by the following:

" _Article 15_

_Confidentiality_

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

justification; and

(b) the Authority shall assess the confidentiality request submitted by the

applicant.

2. This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.".

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_Article 5_

_Amendments to Regulation (EC) No 1935/2004_

Regulation (EC) No 1935/2004 is amended as follows:

(1) Article 9 is amended as follows:

(a) in paragraph 1, point (c) is replaced by the following:

"(c) the Authority shall without delay:

(i) inform the Commission and the other Member States of the application

and shall make the application and any supplementary information

supplied by the applicant available to them; and

(ii) make public the application, relevant supporting information and any

supplementary information supplied by the applicant, in accordance with

Articles 19 and 20.";

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(b) paragraph 2 is replaced by the following:

"2. The Authority shall publish detailed guidelines, following the agreement with

the Commission, concerning 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 following:

"1. The Authority shall make public the application for authorisation, relevant

supporting information and any supplementary information supplied by the

applicant, as well as its scientific 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.";

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(3) Article 20 is replaced by the following:

" _Article 20_

_Confidentiality_

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

justification; and

(b) the Authority shall assess the confidentiality request submitted by the

applicant.

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2. In addition to the items of information referred to in Article 39(2) of Regulation (EC)

No 178/2002 and pursuant to Article 39(3) thereof, the Authority may also grant

confidential treatment with respect to the following items of information, where the

disclosure of such information is demonstrated by the applicant to potentially harm

its interests to a significant degree:

(a) any information provided in detailed descriptions of starting substances and

mixtures used to manufacture the substance subject to the authorisation, the

composition of mixtures, materials or articles in which the applicant intends to

use that substance, the manufacturing methods of those mixtures, materials or

articles, impurities, and migration testing results, except for information which

is relevant to the assessment of safety;

(b) the trademark under which the substance shall be marketed as well as the

tradename of the mixtures, material or articles in which it shall be used, where

applicable; and

(c) any other information deemed confidential within the specific procedural rules

referred 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.".

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_Article 6_

_Amendments to Regulation (EC) No 1331/2008_

Regulation (EC) No 1331/2008 is amended as follows:

(1) in Article 6, the following paragraph is added:

"5. The Authority shall make public the additional information supplied by the applicant

in accordance with Articles 11 and 12.";

(2) Article 11 is replaced by the following:

" _Article 11_

_Transparency_

Where the Commission requests the opinion of the Authority in accordance with

Article 3(2) of this Regulation, the Authority shall make public without delay the

application for authorisation, relevant supporting information and any supplementary

information supplied by the applicant, as well as its scientific opinions, in accordance with

Articles 38 to 39e of Regulation (EC) No 178/2002. The Authority shall also make public

any request for its opinion as well as any extension of period pursuant to Article 6(1) of

this Regulation.";

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(3) Article 12 is replaced by the following:

" _Article 12_

_Confidentiality_

1. The applicant may submit a request to treat certain parts of the information submitted

under this Regulation be as confidential, accompanied by verifiable justification,

upon submission of the application.

2. Where an opinion by the Authority is required in accordance with Article 3(2) of this

Regulation, the Authority shall assess the confidentiality request submitted by the

applicant, in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002.

3. In addition to the items of information referred to in Article 39(2) of Regulation (EC)

No 178/2002 and pursuant to Article 39(3) thereof, the Authority may also grant

confidential treatment with respect to the following items of information, where the

disclosure of such information is demonstrated by the applicant to potentially harm

its interests to a significant degree:

(a) where applicable, information provided in detailed descriptions of starting

substances and starting preparations and on how they are used to manufacture

the substance subject to the authorisation, and detailed information on the

nature and composition of the materials or products in which the applicant

intends to use the substance subject to the authorisation, except for information

which is relevant to the assessment of safety;

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(b) where applicable, detailed analytical information on the variability and stability

of individual production batches of the substance subject to the authorisation,

except for information which is relevant to the assessment of safety.

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.".

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_Article 7_

_Amendments to Regulation (EC) No 1107/2009_

Regulation (EC) No 1107/2009 is amended as follows:

(1) Article 7 is amended as follows:

(a) in paragraph 1, the first subparagraph is replaced by the following:

"An application for the approval of an active substance or for an amendment to the

conditions of an approval shall be submitted by the producer of the active substance

to a Member State (the 'rapporteur Member State'), together with a summary and a

complete dossier as provided for in Article 8(1) and (2) of this Regulation or a

scientifically reasoned justification for not providing certain parts of those dossiers,

demonstrating that the active substance fulfils the approval criteria provided for in

Article 4 of this Regulation. The application shall be submitted 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 following:

"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,

to be as confidential and shall physically separate that information.

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Member States shall assess the confidentiality requests. After consultation with

the Authority, the rapporteur Member States shall decide what information is to

be treated as confidential, in accordance with Article 63.

The Authority, following consultations with the Member States, shall lay down

practical arrangements to ensure the consistency of those assessments.";

(2) Article 10 is replaced by the following:

" _Article 10_

_Public access to the dossiers_

The Authority shall without delay make the dossiers referred to in Article 8, including any

supplementary information supplied by the applicant, available to the public, with the

exception of any information to which the rapporteur Member State has granted

confidential treatment pursuant to Article 63.";

(3) In Article 15, paragraph 1 is replaced by the following:

"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 Authority, no later than three years before the

expiry 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, which shall apply mutatis mutandis.";

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(4) Article 16 is replaced by the following:

" _Article 16_

_Public access to the information for renewal_

The Authority shall assess, without delay, any request for confidentiality and make

available to the public the information provided by the applicant under Article 15 as well

as any other supplementary information submitted by the applicant, except for information

in respect of which confidential treatment has been requested and granted by the Authority

pursuant to Article 63.

The Authority, following consultations with the Member States, shall lay down practical

arrangements to ensure the consistency of those assessments.";

(5) in Article 63, paragraphs 1, 2 and 3 are replaced by the following:

"1. An applicant may submit a request to treat certain parts of the information submitted

under this Regulation as confidential, accompanied by verifiable justification.

2. Confidential treatment may be granted only with respect to the following items of

information, where the disclosure of such information is demonstrated 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;

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(b) the specification of impurity of the active substance and the related methods of

analysis for impurities in the active substance as manufactured, except for the

impurities that are considered to be toxicologically, ecotoxicologically or

environmentally relevant and the related methods of analysis for such

impurities;

(c) results of production batches of the active substance including impurities; and

(d) information on the complete composition of a plant protection product.

2a. Where the Authority assesses confidentiality 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 confidentiality requests under this Regulation, the

following requirements and procedures apply:

(a) confidentiality treatment may only be granted with respect to information listed

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;

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(c) Member States, the Commission and the Authority shall take the necessary

measures so that information for which confidential treatment has been granted

is not made public;

(d) Article 39e of Regulation (EC) No 178/2002 shall also 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 emergency situations, the Member State may

disclose the information referred to in paragraph 2;

(ii) information which forms part of the conclusions of the scientific outputs

delivered by the Authority and which relate to foreseeable effects on

human health, animal health or the environment shall nevertheless be

made public. In that case, Article 39c of Regulation (EC) No 178/2002

shall apply;

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(f) if the applicant withdraws or has withdrawn an application, Member States, the

Commission and the Authority shall respect the confidentiality as granted in

accordance with this Article. Where the withdrawal of the application takes

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 confidentiality has been requested.

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 January 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 September 2006 on the application of the provisions 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).".

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_Article 8_

_Amendments to Regulation (EU) 2015/2283_

Regulation (EU) 2015/2283 is amended as follows:

(1) Article 10 is amended as follows:

(a) paragraph 1 is replaced by the following:

"1. The procedure for authorising the placing on the market within the Union of a

novel food and updating of the Union list provided 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 delay. The Commission shall make a summary of the

application, based on the information referred to in points (a), (b) and (e) of

paragraph 2 of this Article, publicly available.";

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(b) paragraph 3 is replaced by the following:

"3. Where the Commission requests an opinion from the European Food Safety

Authority (the 'Authority'), 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 following:

"2. Within four months from the date on which a valid notification is forwarded by the

Commission in accordance with paragraph 1 of this Article, a Member State or the

Authority may submit to the Commission duly reasoned safety objections to the

placing on the market within the Union of the traditional food concerned. Where the

Authority submits duly reasoned safety objections, it shall make public, without

delay, the notification, pursuant to Article 23, which shall apply mutatis mutandis.";

(3) Article 16 is amended as follows:

(a) in the first paragraph, the following sentence 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.";

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(b) in the second paragraph, the following sentence is added:

"The Authority shall make public the application, relevant supporting information

and any supplementary information supplied by the applicant in accordance with

Article 23.";

(4) Article 23 is replaced by the following:

" _Article 23_

_Transparency and confidentiality_

1. Where the Commission requests the opinion of the Authority in accordance with

Article 10(3) and Article 16 of this Regulation, the Authority shall make public the

application for authorisation, relevant supporting information and any supplementary

information supplied by the applicant, as well as its scientific opinions, in accordance

with Articles 38 to 39e of Regulation (EC) No 178/2002 and with this Article.

2. The applicant may submit a request to treat certain parts of the information submitted

under this Regulation as confidential, accompanied by verifiable justification, upon

submission of the application.

3. Where the Commission requests the opinion of the Authority in accordance with

Article 10(3) and Article 16 of this Regulation, the Authority shall assess the

confidentiality request submitted by the applicant, in accordance with Articles 39 to

39e of Regulation (EC) No 178/2002.

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4. In addition to the items of information referred to in Article 39(2) of Regulation (EC)

No 178/2002 and pursuant to Article 39(3) thereof, the Authority may also grant

confidential treatment with respect to the following items of information, where the

disclosure of such information is demonstrated by the applicant to potentially harm

its interests to a significant degree:

(a) where applicable, information provided in detailed descriptions of starting

substances and starting preparations and on how they are used to manufacture

the novel food subject to the authorisation, and detailed information on the

nature and composition of the specific foods or food categories in which the

applicant intends to use that novel food, except for information which is

relevant to the assessment of safety;

(b) where applicable, detailed analytical information on the variability and stability

of individual production batches, except for information which is relevant to

the assessment of safety.

5. Where the Commission does not request the Authority's opinion pursuant to

Articles 10 and 16 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 4 of this Article shall apply mutatis mutandis.

6. This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.".

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_Article 9_

_Amendments to Directive 2001/18/EC_

Directive 2001/18/EC is amended as follows:

(1) in Article 6, the following paragraph is inserted:

"2a. The notification referred to in paragraph 1 shall be submitted in accordance with

standard data formats, where they exist under Union law.";

(2) in Article 13, the following paragraph is inserted:

"2a. The notification referred to in paragraph 1 shall be submitted in accordance with

standard data formats, where they exist under Union law.";

(3) Article 25 is replaced by the following:

" _Article 25_

_Confidentiality_

1. The notifier may submit a request to the competent authority to treat certain parts of

the information submitted under this Directive as confidential, accompanied by

verifiable justification, in accordance with paragraphs 3 and 6.

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2. The competent authority shall assess the confidentiality request submitted by the

notifier.

3. Upon request of a notifier, the competent authority may grant confidential treatment

only with respect to the following items of information, upon verifiable justification,

where the disclosure of such information is demonstrated by the notifier to

potentially harm its interests to a significant degree:

(a) items of information referred to in points (a), (b) and (c) of Article 39(2) of

Regulation (EC) No 178/2002;

(b) DNA sequence information, except for sequences used for the purpose of

detection, identification and quantification of the transformation event; and

(c) breeding patterns and strategies.

4. The competent authority shall, after consultation with the notifier, decide which

information is to be treated as confidential and shall inform the notifier of its

decision.

5. Member States, the Commission and the relevant Scientific Committee(s) shall take

the necessary measures to ensure that confidential information notified or exchanged

under this Directive is not made public.

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6. The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall

also apply mutatis mutandis.

7. Notwithstanding paragraphs 3, 5 and 6 of this Article:

(a) where urgent action is essential to protect human health, animal health or the

environment, such as in emergency situations, the competent authority may

disclose the information referred to in paragraph 3; and

(b) information which forms part of the conclusions of the scientific outputs

delivered by the relevant Scientific Committee(s) or the conclusions of the

assessment reports and which relate to foreseeable effects on human health,

animal health or the environment shall nevertheless be made public. In that

case Article 39c of Regulation (EC) No 178/2002 shall apply.

8. In the event of a withdrawal of the notification by the notifier, Member States, the

Commission and the relevant Scientific Committee(s) shall respect the

confidentiality as granted by the competent authority in accordance with this Article.

Where the withdrawal of the notification takes place before the competent authority

has decided on the relevant confidentiality request, Member States, the Commission

and the relevant Scientific Committee(s) shall not make public the information for

which confidentiality has been requested.";

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(4) in Article 28, the following paragraph is added:

"4. Where the relevant Scientific Committee is consulted in accordance with paragraph 1

of this Article, it shall make public without delay the notification, relevant supporting

information and any supplementary information supplied by the notifier, as well as

its scientific opinions, with the exception of any information to which the competent

authority has granted confidential 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 submitted to the Authority before … [18 months after the date of entry

into force of this Regulation].

2. The term of office of the members of the Management Board of the Authority (the

"Management Board") who are in office on 30 June 2022, shall expire on that date.

Notwithstanding the dates of application referred 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.

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3. Notwithstanding the dates 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 appointed according to the selection and appointment procedure laid

down in point 5 of Article 1 start their term of office.

_Article 11_

_Entry into force_

This Regulation shall enter into force on the twentieth day following that of its publication in the

_Official Journal of the European Union_ .

It shall apply from … [18 months after the date of entry into force of this Regulation].

However, points 4 and 5 of Article 1 shall apply from 1 July 2022.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at …,

_For the European Parliament_ _For the Council_

_The President_ _The President_

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