Source: EURLEX
Language: en
Format: md

**Council of the**
**European Union**

**Interinstitutional File:**

**2018/0088(COD)**

**INFORMATION NOTE**

**Brussels, 8 May 2019**
**(OR. en)**

**8440/19**

**CODEC 900**
**AGRILEG 79**
**DENLEG 53**
**MI 359**
**SAN 207**
**CONSOM 141**
**RECH 214**
**PE 165**

From: General Secretariat of the Council

To: Permanent Representatives Committee/Council

Subject: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND
OF THE COUNCIL on the transparency and sustainability of the EU risk
assessment in the food chain amending Regulation (EC) No 178/2002 [on
general food law], Directive 2001/18/EC [on the deliberate release into the
environment of GMOs], Regulation (EC) No 1829/2003 [on GM food and
feed], Regulation (EC) No 1831/2003 [on feed additives], Regulation (EC)
No 2065/2003 [on smoke flavourings], Regulation (EC) No 1935/2004 [on
food contact materials], Regulation (EC) No 1331/2008 [on the common
authorisation procedure for food additives, food enzymes and food
flavourings], Regulation (EC) No 1107/2009 [on plant protection products]
and Regulation (EU) No 2015/2283 [on novel foods]

          - Outcome of the European Parliament's first reading

(Strasbourg, 15 to 18 April 2019)

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**I.** **INTRODUCTION**

In accordance with the provisions of Article 294 of the TFEU and the joint declaration on practical

arrangements for the codecision procedure **[1]**, a number of informal contacts have taken place

between the Council, the European Parliament and the Commission with a view to reaching an

agreement on this dossier at first reading, thereby avoiding the need for second reading and

conciliation.

In this context, the rapporteur, Pilar AYUSO (EPP, ES), presented a compromise amendment

(amendment number 171) to the proposal for a Regulation on behalf of the Committee on the

Environment, Public Health and Food Safety. This amendment had been agreed during the informal

contacts referred to above.

**II.** **VOTE**

When it voted on 17 April 2019, the plenary adopted the compromise amendment (amendment

number) to the proposal for a Regulation. The Commission's proposal as thus amended constitutes

the Parliament's first-reading position which is contained in its legislative resolution as set out in the

Annex hereto **[2]** .

The Parliament's position reflects what had been previously agreed between the institutions. The

Council should therefore be in a position to approve the Parliament's position.

The act would then be adopted in the wording which corresponds to the Parliament's position.

**1** OJ C 145, 30.6.2007, p. 5.
**2** The version of the Parliament's position in the legislative resolution has been marked up to
indicate the changes made by the amendments to the Commission's proposal. Additions to
the Commission's text are highlighted in _**bold and italics.**_ The symbol " ▌" indicates deleted
text.

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**ANNEX**

**(17.4.2019)**

## **Transparency and sustainability of the EU risk assessment in the food chain** *****I**

**European Parliament legislative resolution of 17 April 2019 on the proposal for a Regulation**
**of the European Parliament and of the Council on the transparency and sustainability of the**
**EU risk assessment in the food chain amending Regulation (EC) No 178/2002 [on general food**
**law], Directive 2001/18/EC [on the deliberate release into the environment of GMOs],**
**Regulation (EC) No 1829/2003 [on GM food and feed], Regulation (EC) No 1831/2003 [on feed**
**additives], Regulation (EC) No 2065/2003 [on smoke flavourings], Regulation (EC) No**
**1935/2004 [on food contact materials], Regulation (EC) No 1331/2008 [on the common**
**authorisation procedure for food additives, food enzymes and food flavourings], Regulation**
**(EC) No 1107/2009 [on plant protection products] and Regulation (EU) No 2015/2283 [on**
**novel foods] (COM(2018)0179 – C8-0144/2018 – 2018/0088(COD)**

**(Ordinary legislative procedure: first reading)**

_The European Parliament,_

–
having regard to the Commission proposal to Parliament and the Council (COM(2018)0179),

–
having regard to Article 294(2) and Articles 43, 114 and 168(4)(b) of the Treaty on the
Functioning of the European Union, pursuant to which the Commission submitted the
proposal to Parliament (C8-0144/2018),

–
having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis,

–
having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–
having regard to the opinion of the European Economic and Social Committee of 19
September 2018 **[1]**,

– having regard to the opinion of the Committee of the Regions of 10 October 2018 **[2]**,

–
having regard to the provisional agreement approved by the committee responsible under
Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative
by letter of 15 February 2019 to approve Parliament’s position, in accordance with Article
294(4) of the Treaty on the Functioning of the European Union,

–
having regard to Rules 59 and 39 of its Rules of Procedure,

–
having regard to the report of the Committee on the Environment, Public Health and Food
Safety and the opinions of the Committee on Fisheries and the Committee on Legal Affairs
(A8-0417/2018),

**1** OJ C 440, 6.12.2018, p. 158.
**2** OJ C 461, 21.12.2018, p. 225.

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1. Adopts its position at first reading hereinafter set out **[1]** ;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially
amends or intends to substantially amend its proposal;

3. Instructs its President to forward its position to the Council, the Commission and the national
parliaments.

**1** This position replaces the amendments adopted on 11 December 2018 (Texts adopted,
P8_TA(2018)0489).

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**P8_TC1-COD(2018)0088**

**Position of the European Parliament adopted at first reading on 17 April 2019 with a view to**

**the adoption of Regulation (EU) 2019/… 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**

**(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.

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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.

**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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_**(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.

(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.

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(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.**_

_**(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.**_

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(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.**_

(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.

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_**(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.

(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’).

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(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.**_

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_**(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.**_

(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.

**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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(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.

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(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.

(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.

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(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**_ .

(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.

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(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.

(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.

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(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.

(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.**_

**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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(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.**_

(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 aim**_ ed _**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.**_

_**(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**_ _**[4]**_ _**.**_

_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/EE (OJ L 41, 14.2.2003, p. 26).**_
_4_ _**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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# ANNEX GIP.2 EN

( _**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.

( _**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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# ANNEX GIP.2 EN

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:

"SECTION 1a

RISK 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;

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(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; ▌

(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.";**_

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(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**_ .";

(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;

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# ANNEX GIP.2 EN

(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.

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.

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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.";

(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.";

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# ANNEX GIP.2 EN

(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.**_

_**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.";**_

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# ANNEX GIP.2 EN

_**(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;

(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;**_

▌

8440/19 SP/mv 38

# ANNEX GIP.2 EN

( _**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;

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

Board shall ensure that the broadest possible geographical distribution is

achieved in the ▌ appointments.

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# ANNEX GIP.2 EN

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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# ANNEX GIP.2 EN

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.

5 _**f**_ . 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 5 _**f**_ .";

8440/19 SP/mv 41

# ANNEX GIP.2 EN

(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.**_

8440/19 SP/mv 42

# ANNEX GIP.2 EN

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 o**_ f

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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# ANNEX GIP.2 EN

_**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.**_

8440/19 SP/mv 44

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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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# ANNEX GIP.2 EN

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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# ANNEX GIP.2 EN

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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# ANNEX GIP.2 EN

Article 32 _**d**_

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;

8440/19 SP/mv 48

# ANNEX GIP.2 EN

(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;

(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;

8440/19 SP/mv 49

# ANNEX GIP.2 EN

(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 32 _**d**_ ;

(g) the annual report of its activities;

(h) requests from the European Parliament, from the Commission or from a

Member State for scientific opinions which have been refused or

modified and the 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.

8440/19 SP/mv 50

# ANNEX GIP.2 EN

_**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.";

(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’).

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# ANNEX GIP.2 EN

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.";**_

(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.";

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# ANNEX GIP.2 EN

(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.**_

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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;

(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 [1] and ( _**EU) 2018/1725**_ [2] of the European Parliament and of

the Council _**.**_

**1** 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).
**2** 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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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.

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. ▌";

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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.**_

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).**_

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_*******_ _**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 1367/2006by …**_  _**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.**_

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_**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.**_

_**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:";

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(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;";

(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.";

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(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.";

(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:";

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(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

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(b) breeding patterns and strategies.

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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# ANNEX GIP.2 EN

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.";

(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.";

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(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.";

(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.";

(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.";

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(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.";

(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 s _**uch 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.";

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(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.

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.";

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(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.";

(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**_ .";

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(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;**_

( _**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.**_

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_**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;**_

_**(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;**_

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_**(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;**_

_**(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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# ANNEX GIP.2 EN

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.";**_

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# ANNEX GIP.2 EN

(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.";

(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.

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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.

_**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.**_

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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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# ANNEX GIP.2 EN

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."**_ ;

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(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.**_

▌

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

notifier .
▌

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_**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.**_

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

_**shall also apply mutatis mutandis.**_

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_**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.".

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# ANNEX GIP.2 EN

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.**_

_**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.**_

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# ANNEX GIP.2 EN

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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# ANNEX GIP.2 EN