(2a)

Risk management, assessment and communication activities should be based on a thorough application of, inter alia, the precautionary principle.

(4)

It is therefore necessary to ensure a  comprehensive and continuous risk communication process throughout risk analysis, involving Union and national risk assessors and risk managers. That process should be combined with an open dialogue between all interested parties to ensure the coherence and consistency within the risk analysis process.

(4)

It is therefore necessary to ensure a  transparent, independent, continuous and inclusive risk communication process throughout risk analysis, involving Union and national risk assessors and risk managers. That process should regain citizens' trust that the whole process is underpinned by the objective of this Regulation, which is to ensure high level of human life and health and the protection of consumers' interests. That process should also be capable of contributing to a participatory and open dialogue between all interested parties, particularly the public, to ensure prevalence of public interest only, accuracy, comprehensiveness, transparency , consistency , and accountability within the risk analysis process.

(4a)

On signing trade agreements, the Union needs to ensure that the food legislation of third-country partners is at least as protective of food safety as Union law, so as to guarantee consumer safety and prevent unfair competition with European products.

(5)

Particular emphasis should be placed on explaining in a coherent, appropriate and timely manner not only risk assessment findings themselves but also how these are utilized to help inform risk management decisions along with other legitimate factors, where relevant.

(5)

Particular emphasis should be placed on explaining in an accurate, clear , objective and timely manner not only risk assessment findings themselves but also how these are utilized to help inform risk management decisions along with other legitimate factors, where relevant.

(6)

To this effect, it is necessary to establish general objectives and principles of risk communication , taking into account the respective roles of risk assessors and managers.

(6)

To this effect, it is necessary to establish general objectives and principles of risk communication . In this connection , the respective roles of risk assessors and managers should be taken into account, while guaranteeing their independence .

(8)

The general plan should identify the key factors to be taken into account when risk communications’ activities are considered, such as the different levels of risk, the nature of the risk and its potential public health impact, who and what are directly or indirectly affected by the risk, the levels of risk exposure, the ability to control risk and other factors that influence risk perception including the level of urgency as well as the applicable legislative framework and relevant market context. The general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure coherent risk communication.

(8)

The general plan should lay down the practical arrangements for making available to the public the necessary information to achieve a high level of transparency in the risk management process. It should identify the key factors to be taken into account when risk communications’ activities are considered, such as the different levels of risk, the nature of the risk and its potential impact on public health, animal health and the environment , who and what are directly or indirectly affected by the risk, the levels of risk exposure, the ability to minimise or control risk and other factors that influence risk perception including the level of urgency as well as the applicable legislative framework and relevant market context. The general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure coherent risk communication.

(9)

Transparency of the risk assessment process contributes to the Authority acquiring greater legitimacy in the eyes of the consumers and general public in pursuing 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 maintain the confidence of the general public and other interested parties in the risk analysis process underpinning Union food law and in particular in the risk assessment, including the organisation and independence of the Authority and transparency.

(9)

Improving transparency of the risk assessment process would contribute to the Authority acquiring greater legitimacy in the eyes of the consumers and general public in pursuing its mission, increase their confidence in its work and ensure that the Authority is more accountable to the Union citizens in a democratic system. It is therefore essential to rebuild the confidence of the general public and other interested parties in the risk analysis process underpinning Union food law and in particular in the risk assessment, including the organisation, functioning and independence of the Authority and transparency.

(10)

It is appropriate to align the composition of the Management Board of the Authority to the Common Approach on decentralised agencies, in accordance with the Joint Statement of the European Parliament, the Council of the European Union and the European Commission on decentralised agencies of 2012  (22) .

(11)

Experience shows that the role of the Management Board of the Authority is focussed 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 in the Management Board of the Authority, while providing that those representatives should have experience in particular on risk assessment.

(11)

Experience shows that the role of the Management Board of the Authority is focussed 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, the Commission, the European Parliament , as well as civil society and industry associations in the Management Board of the Authority, while providing that those representatives should have experience in particular on risk assessment and that any conflict of interest is avoided.

(12)

The Management Board should be selected in such a way as to secure the highest standards of competence and a broad range of relevant experience available amongst the representatives of the Member States, the European Parliament and the Commission.

(12)

The Management Board should be selected in such a way as to secure the highest standards of competence and commitment to the protection of health and the environment and a broad range of relevant experience available amongst the representatives of the Member States, the European Parliament and the Commission.

(13)

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 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 .

(13)

The Fitness Check of the General Food Law identified certain shortcomings in the long-term capacity of the Authority to maintain its high-level expertise through expert personnel . Moreover , there has been a decrease in the number of candidates applying to be members of the Scientific Panels, and the reason for this decline should be examined . Six Member States provide two thirds of the experts on the scientific panels. As the United Kingdom currently provides approximately 20 % of the national experts, the problem will be further exacerbated with the withdrawal of the United Kingdom from the Union. In order to tackle this phenomenon more effectively, the system has thus to be strengthened and promoted, must encourage candidates to apply and Member States should support the dissemination of the Authority’s calls for expressions of interest for membership of the Scientific Panels and Scientific Committee, to ensure that a sufficient pool of independent experts is available, by undertaking support actions and using incentives and rewards to increase the level of participation and the degree of interest in seeking to engage in it.

(14)

To preserve the independence of the risk assessment from risk management and from other interests at Union level, it is appropriate that the nomination of the members of the Scientific Panels by the Member States , their selection by the Executive Director of the Authority and their appointment by the Management Board of the Authority are based on strict criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each Panel. It is also essential to this end that the Executive Director whose function is to defend EFSA’s interests and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts. Further measures should also be put in place to ensure that scientific experts have the means to act independently.

(14)

To preserve the independence of the risk assessment from risk management and from other interests at Union level, it is appropriate that the nomination of the members of the Scientific Panels, their selection by the Executive Director of the Authority and their appointment by the Management Board of the Authority are based on strict criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each Panel. It is also essential to this end that the Executive Director, who is the legal representative of the Authority and whose function is to defend EFSA’s interests and to monitor its performance and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts. Further measures, including proper financial compensation, should also be put in place to ensure that scientific experts have the means to act independently and to dedicate sufficient time to their risk assessment work for the Authority.

(15)

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 Authority’s Scientific Panels. In particular, the Authority should organise the preparatory work supporting the Panels’ tasks, 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 the Panels.

(15)

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 Authority’s Scientific Panels. In particular, the Authority should organise the preparatory work supporting the Panels’ tasks, 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 the Panels. This should be without prejudice to the independence of the Authority’s scientific assessments.

(16)

Authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with Union safety requirements given the scientific knowledge in its possession. This principle is based on the premise that public health is better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market, instead of the public authorities having to prove that a subject matter is unsafe in order to be able to ban it from the market. Moreover, public money should not be used to commission costly studies that will in the end help the industry to place a product on the market. According to this principle and in accordance with applicable regulatory requirements, in support of applications for an authorisation under Union sectoral food law applicants are required to submit relevant studies, including tests, to demonstrate the safety and in some cases the efficacy of a subject matter.

(16)

Authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with Union safety requirements given the scientific knowledge in its possession. This principle is based on the premise that public health and the environment are better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market, instead of the public authorities having to prove that a subject matter unsafe in order to be able to ban it from the market. Moreover, public money should not be used to commission costly studies that will in the end help the industry to place a product on the market. According to this principle and in accordance with applicable regulatory requirements, in support of applications for an authorisation under Union sectoral food law applicants are required to submit relevant studies, including tests, to demonstrate the safety and in some cases the efficacy of a subject matter.

(16a)

A comparison of Union agencies shows that the Authority needs up to 55 months for an authorisation procedure or five times longer than the European Medicines Agency (EMA). This discourages firms from investing in innovative products and reduces Union’s competitiveness in the long run. In addition, long authorisation procedures weaken confidence in the Authority. It is therefore urgently advisable to ensure the efficiency of the risk assessment by means of better human and financial resources.

(17)

Provisions exist on the content of applications for authorisations. It is essential that the application for authorisation submitted to the Authority for its risk assessment meets the applicable specifications to ensure the best quality scientific assessment by the Authority. Applicants and in particular small- and medium-sized enterprises do not always have a clear understanding of these specifications. It should be thus appropriate that the Authority provides advice to a potential applicant, upon request, on the applicable rules and the required content of an application for authorisation, before an application is formally submitted , while not entering into the design of the studies to be submitted that remain the applicant’s responsibility. To ensure the transparency of this process, the advice of the Authority should be made public.

(17)

Provisions exist on the content of applications for authorisations. It is essential that the application for authorisation submitted to the Authority for its risk assessment meets the applicable specifications to ensure the best quality scientific assessment by the Authority. Applicants and in particular small- and medium-sized enterprises do not always have a clear understanding of these specifications. It should be thus appropriate that the Authority provides advice to a potential applicant, upon request, on the applicable rules and the required content of an application for authorisation, before an application is formally submitted. By … [ 36 months after the entry into force of this amending Regulation ] , the Commission should evaluate the impact of the general advice provided on the functioning of the Authority. In particular, the Commission should evaluate its impact on the allocation of the Authority's resources and on its independence.

(18)

The Authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation under Union food law. To this end, it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the Authority when commissioned. Information about the notified studies should be made public only once a corresponding application for authorisation has been made public in accordance with the applicable rules on transparency.

(18)

The Authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation or renewal under Union food law. To this end, it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the Authority when commissioned in the Union or beyond . Information about the notified studies should be made public only once a corresponding application for authorisation or renewal has been made public in accordance with the applicable rules on transparency.

(20)

There are certain public concerns about the Authority’s assessment in the area of authorisation being primarily based on industry studies. The Authority already makes 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 ensuring that the Authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure, it is appropriate to provide for a 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 when the studies submitted by industry included in an application for authorisation are made public, under the transparency rules of this Regulation.

(20)

There are certain public concerns about the Authority’s assessment in the area of authorisation being primarily based on industry studies. In the case of a new application for an authorisation or a renewal procedure, the Authority should always conduct searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment and, where necessary, demand additional studies. The Authority should provide public access to all relevant scientific literature on the matter, which it holds. In order to provide an additional level of guarantee ensuring that the Authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure, it is appropriate to provide for a 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 for authorisation have been made public, under the transparency rules of this Regulation.

(21)

Studies, including tests, submitted by business operators in support of applications for authorisations under Union sectoral food law 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 may arise in some cases and this is why national systems are in place to verify such compliance. It is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced auditing system whereby Member State controls on the implementation of those principles by the laboratories carrying out such studies and tests would be verified by the Commission.

(21)

Studies, including tests, submitted by business operators in support of applications for authorisations under Union sectoral food law should be based on independent peer-reviewed literature or comply with internationally recognised standards and Good Laboratory Practice (GLP) 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 may arise in some cases and this is why national systems are in place to verify such compliance. It is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced auditing system whereby Member State or third-country controls , in collaboration with the Commission’s Directorate for Health and Food Audits and Analysis on the implementation of those principles by the laboratories carrying out such studies and tests in the Union and in third countries would be verified by the Commission.

(21a)

Sufficient flexibility ought to be built into the process so that new insights into serious health adverse effects can be promptly taken into consideration, even when they are not specifically covered by regulatory data requirements.

(22)

Food safety is a sensitive matter of prime interest for all Union citizens. While maintaining the principle that the burden is on the industry to prove compliance with Union requirements, it is important to establish an additional verification tool to address specific cases of high societal importance where there is a controversy on safety issues, namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment. Considering that it would be financed by the Union budget and that the use of this exceptional verification tool should remain proportionate, the Commission should be responsible for triggering the commissioning of such verification studies. Account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake (for example new scientific developments becoming available).

(22)

Food safety is a sensitive matter of prime interest for all Union citizens. While maintaining the principle that the burden is on the industry to prove compliance with Union requirements, it is important to establish an additional verification tool to address specific cases of high societal importance where there is a controversy on safety issues, namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment. Considering that it would be financed by the Union budget and that the use of this exceptional verification tool should remain proportionate, the Commission should , in case of divergent scientific findings, be responsible for triggering the commissioning of such verification studies. Account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake in the risk assessment process (for example new scientific developments becoming available).

(23a)

The Aarhus Convention establishes a number of rights of the public with regard to the environment. The Aarhus Convention provides for the right of everyone to receive environmental information that is held by public authorities, the right to participate in environmental decision-making, and the right to review procedures to challenge public decisions that have been made without respecting the two aforementioned rights or environmental law in general.

(24)

The European Citizens’ Initiative ‘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 application (23).

(24)

As a Party to the Aarhus Convention, the Union has recognised that, in the field of the environment, improved access to information and public participation in decision-making enhance the quality and the implementation of decisions, contribute to public awareness of environmental issues, give the public the opportunity to express its concerns and enable public authorities to take due account of such concerns. The European Citizens’ Initiative ‘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 application (23).

(25a)

Using the Board of Appeal of the European Chemicals Agency as its model, as set out in Articles 89 to 93 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council  (1a) , an EFSA Board of Appeal should be established by means of delegated acts.

(27)

To determine what level of disclosure strikes the appropriate balance, the relevant rights of the public to transparency in the risk assessment process, should be weighted up against the rights of commercial applicants, taking into account the objectives of Regulation (EC) No 178/2002.

(27)

To determine what level of proactive disclosure strikes the appropriate balance, the need to ensure transparency in the risk assessment process, should be weighted up against the rights of commercial applicants, taking into account the objectives of Regulation (EC) No 178/2002, of a high level of protection of human life and health, the protection of consumers' interests, as well as the protection of animal health and welfare, plant health and the environment .

(27a)

The provisions on active dissemination laid down in this Regulation are not meant to limit, in any manner, the scope of the rights provided for by Regulations (EC) No 1049/2001 and (EC) No 1367/2006.

(30)

It is also necessary to set out specific requirements with respect to the protection of personal data for the purposes of the transparency of the risk assessment process taking into account Regulation (EC) No 45/2001 of the European Parliament and of the Council (24) and Regulation (EU) 2016/679 of the European Parliament and of the Council (25). 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.

(30)

It is also necessary to refer, for the protection and confidentiality of personal data for the purposes of the transparency of the risk assessment process, to Regulation (EC) No 45/2001 of the European Parliament and of the Council (24) and Regulation (EU) 2016/679 of the European Parliament and of the Council (25). 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. For the purpose of ensuring the transparency, independence, sustainability and reliability of the risk assessment process, in particular to avoid conflicts of interest, it is considered necessary and proportionate to publish the names of any individual designated by the Authority to contribute to the Authority’s decision making process, including in the context of the adoption of guidance documents.

(31)

For the purposes 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 and software packages should be developed. In order to ensure uniform conditions for the implementation of Regulation (EC) No 178/2002 with regard to the adoption of standard data formats and software packages, 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 (26).

(31)

For the purposes 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 and software packages should be developed. In order to ensure uniform and harmonised conditions for the implementation of Regulation (EC) No 178/2002 with regard to the adoption of standard data formats and software packages, 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 (26).

(33)

Furthermore, in order to assess the effectiveness and efficiency of the different provisions applying to the Authority, it is also appropriate to provide for a Commission evaluation of the Authority , in accordance with the Common Approach on Decentralised Agencies . The evaluation should, in particular, review the procedures for selecting the members of Scientific Committee and Panels, for their degree of transparency, cost-effectiveness, and suitability to ensure independence and competence, and to prevent conflicts of interests.

(33)

Furthermore, in order to assess the effectiveness and efficiency of the different provisions applying to the Authority, it is also appropriate to conduct an independent evaluation of the Authority. The evaluation should, in particular, review the procedures for selecting the members of Scientific Committee and Panels, for their degree of transparency, cost-effectiveness, and suitability to ensure independence and competence, and to prevent conflicts of interests.

(33a)

The Seventh European Environment Action Programme has prioritised the development and realisation of pathways to address the combined effects of chemicals on human health and the environment. Assessment of ‘cocktail effects’ requires a cross-sectoral approach, closer cooperation between monitoring agencies at European level and the formulation of suitable procedures.

(35)

For the purposes of ensuring transparency of the risk assessment process, it is also necessary to extend the scope of Regulation (EC) No 178/2002, currently limited to food law, to also cover applications for authorisations in the context of Regulation (EC) No 1831/2003 as regards feed additives, Regulation (EC) No 1935/2004 as regards food contact materials and Regulation (EC) No 1107/2009 as regards plant protection products.

(35)

For the purposes of ensuring the transparency and independence of the risk assessment process, it is also necessary to extend the scope of Regulation (EC) No 178/2002, currently limited to food law, to also cover applications for authorisations in the context of Regulation (EC) No 1831/2003 as regards feed additives, Regulation (EC) No 1935/2004 as regards food contact materials and Regulation (EC) No 1107/2009 as regards plant protection products.

(36)

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, including those flowing from the Aarhus Convention  (1) , against the rights of commercial applicants, taking into account the specific objectives of sectoral Union legislation as well as experienced gained. Accordingly, it is necessary to amend Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1831/2003, Regulation (EC) No 1935/2004 and Regulation (EC) No 1107/2009 to provide for additional confidential items to those set out in Regulation (EC) No 178/2002.

(36)

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 , including the right to benefit from proactive information related to the risk assessment process, against the rights of commercial applicants, taking into account the specific objectives of sectoral Union legislation as well as experienced gained. Accordingly, it is necessary to amend Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1831/2003, Regulation (EC) No 1935/2004 and Regulation (EC) No 1107/2009 to provide for additional confidential items to those set out in Regulation (EC) No 178/2002. The provisions on active dissemination laid down in this Regulation and the assessment of a confidentiality request by the Authority should not in any manner limit the scope of the rights provided by Regulations (EC) No 1049/2001 and (EC) No 1367/2006.

(36a)

The Fitness Check of the General Food Law also highlighted a lack of transparency of the risk management process. There is a need to better inform the public on the risk management options under consideration, the level of protection to consumer and animal health and the environment that each of these options would achieve, as well as on the factors, other than the results of the risk assessment, which are taken into account by the risk managers, and how they are weighed up against each other in the decision-making process.

(37)

In order to further strengthen the link between risk assessors and risk managers at Union and national levels as well as the coherence and consistency of risk communication , the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to adopt a general plan on risk communication on matters covering the agri-food chain. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(37)

In order to improve the interactive exchange of information, throughout the risk analysis process, amongst the risk assessors and risk managers at Union and national levels, as well as with other stakeholders of the food chain such as economic operators, consumer and other civil society organisations , the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to adopt a general plan on risk communication on matters covering the agri-food chain. The general plan on risk communication should lay down the practical arrangements for making available to the public the necessary information to achieve a high level of transparency of the risk management process. Therefore, it is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(37a)

Provisions regarding what information should be made public should be without prejudice to Regulation (EC) No 1049/2001, as well as national or Union law regarding public access to official documents.

(38)

In order to enable the Authority and the business operators to adapt to the new requirements while ensuring that the Authority continues its smooth operation, it is necessary to provide for transitional measures for the application of this Regulation.

(38)

In order to enable the Authority , Member States, the Commission and the business operators to adapt to the new requirements while ensuring that the Authority continues its smooth operation, it is necessary to provide for transitional measures for the application of this Regulation.

(39a)

Since the amendments contained in this proposal serve to transfer far-reaching competencies for risk assessment and confidentiality checks to the Authority, a significant increase in the budget for the Authority pursuant to Annex 3 of the Commission’s proposal is necessary. The financing proposal is compatible with the current multiannual financial framework but may entail the use of special instruments as defined in Council Regulation (EU, Euratom) No 1311/2013. Should discussions between the European Parliament and the Member States on the Union budget not leave sufficient room for the necessary budgetary resources, then the Commission would have to propose an alternative financing proposal under a delegated act.

(40a)

Recent food safety incidents have demonstrated the need to establish appropriate measures in emergency situations ensuring that all foods, whatever their type and origin, and all feed should be subject to common measures in the event of a serious risk to human health, animal health or the environment. This comprehensive approach to emergency food safety measures should enable effective action to be taken, avoiding artificial disparities in the treatment of any serious risk to food or feed through a harmonised joint food alerts management procedure.

(-1)

(-1a)

(a)

promote awareness and understanding of the specific issues under consideration during the entire risk analysis process;

(a)

promoting awareness and understanding of the specific issues under consideration during the entire risk analysis and management process;

(b)

promote consistency and transparency in formulating risk management recommendations;

(b)

promoting consistency, transparency and clarity in formulating risk management options , recommendations and decisions ;

(c)

provide a sound basis for understanding risk management decisions;

(c)

providing a sound scientific basis for understanding risk management decisions , including information on:

(d)

foster public understanding of the risk analysis process so as to enhance confidence in its outcome;

(d)

fostering public understanding of the risk analysis process so as to enhance confidence in its outcome , including the provision of clear and consistent information regarding the respective tasks, powers and responsibilities of risk assessors and risk managers;

(e)

promote appropriate involvement of all interested parties; and,

(e)

promoting the balanced involvement of all interested parties , including economic operators of the food chain, consumers and other civil society organisations ;

(f)

ensure appropriate exchange of information with interested parties in relation to risks associated with the agri-food chain.

(f)

ensuring a transparent and equitable exchange of information with the interested parties referred to in point (e) in relation to risks associated with the agri-food chain;

(fa)

informing consumers about risk prevention strategies; and

(fb)

combating the dissemination of false information and the sources thereof.

(a)

ensure that accurate, appropriate and timely information is interactively exchanged, based on the principles of transparency, openness, and responsiveness;

(a)

ensure that accurate, complete and timely information is interactively exchanged 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;

(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;

(c)

take into account risk perceptions;

(c)

address risk perceptions;

(d)

facilitate understanding and dialogue amongst all interested parties; and,

(d)

facilitate understanding and dialogue amongst all interested parties;

(e)

be accessible, including to those not directly involved in the process, while taking into account confidentiality and protection of personal data.

(e)

be accessible, including to those not directly involved in the process, while taking into account confidentiality and protection of personal data ; and

(ea)

formulate approaches to better communicate the difference between hazard and risk.

(a)

identify the key factors that need to be taken into account when considering the type and level of risk communications’ activities needed;

(a)

identify the key factors that need to be taken into account when considering the type and level of risk communications’ activities needed;

(b)

identify the appropriate main tools and channels to be used for risk communication purposes, taking into account the needs of relevant target audience groups; and,

(b)

identify the appropriate main tools and channels to be used for risk communication purposes, taking into account the need to ensure the balanced involvement of all interested parties, including economic operators of the food chain, and consumer and other civil society organisations;

(c)

establish appropriate mechanisms in order to strengthen coherence of risk communication amongst risk assessors and risk managers and ensure an open dialogue amongst all interested parties.

(c)

establish appropriate mechanisms in order to strengthen coherence of risk communication amongst risk assessors and risk managers, including by systematically acknowledging and explaining divergences in scientific assessment or in the perception of the acceptable level of risk;

(ca)

lay down the practical arrangements and a timeline for making the information referred to in Article 55a(1) available to the public.

(1a)

(1b)

(1c)

(1d)

(b)

to promote and coordinate the development of uniform risk assessment methodologies in the fields falling within its mission;

‘(b)

to promote and coordinate in a cross-cutting approach the development of uniform methods for risk assessment in the areas within its mission , in particular taking into account the “cocktail effects” of chemical substances which may have an impact on human health and the environment ;’

(a)

two members and the alternate members appointed by the Commission and representing the Commission, with the right to vote.

(a)

two members and the alternate members appointed by the Commission and representing the Commission, with the right to vote.

(b)

one member appointed by the European Parliament, with the right to vote.

(b)

two representatives appointed by the European Parliament, with the right to vote.

(c)

four members with the right to vote representing civil society and food chain interests namely, one from consumers organisations, one from environmental non-governmental organisations, one from farmers organisations and one from industry organisations. Those members shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint those members.

(c)

six members with the right to vote representing civil society and food chain interests namely, one from consumers organisations, one from environmental non-governmental organisations, one from public health non-governmental organisations , one from farmers organisations , one from the agro-chemical organisations and one from food industry organisations. Those members shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint those members.

(—

(a)

The Executive Director, after consulting the Management Board, shall send to the Member States the request for the specific multidisciplinary expertise needed in each Scientific Panel and shall indicate the number of experts to be nominated by the Member States . The Executive Director shall notify the Member States of the Authority’s independence policy and implementing rules applicable to Scientific Panels’ members. Member States shall launch a call for interest as a basis for their nominations. The Executive Director shall inform the Management Board of the requests sent to the Member States.

(a)

The Executive Director, after consulting the Management Board, shall publish 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, and shall inform the Member States . The call shall lay down the specific multidisciplinary expertise needed in each Scientific Panel and shall indicate the number of experts required .

(b)

Member States shall nominate experts with a view to collectively reach the number indicated by the Executive Director. Each Member State shall nominate at least 12 scientific experts. Member States may nominate nationals of other Member States .

(b)

Member States shall ensure the broad dissemination of the call for expression of interest across the scientific community. They may also nominate experts for the fields indicated , provided that such nominations are made on the basis of a national call for expression of interest .

(c)

On the basis of the nominations made by Member States , the Executive Director shall draw for each Scientific Panel a list of experts larger than the number of members to be appointed. The Executive Director may not draw up such a list where he/she can justify that the nominations received do not allow him, given the criteria for selection set up in point d) of this paragraph, to draw up a larger list. The Executive Director shall submit the list to the Management Board for appointment.

(c)

On the basis of the applications and nominations received and in accordance with the Authority’s independence policy and implementing rules applicable to Scientific Panels’ members , the Executive Director shall draw for each Scientific Panel a list of experts larger than the number of members to be appointed. The Executive Director may not draw up such a list where he or she can justify that the applications and nominations received do not allow him or her , given the criteria for selection set up in point (d) of this paragraph, to draw up a larger list. The Executive Director shall submit the list to the Management Board for appointment.

(d)

The nominations by the Member States, the selection by the Executive Director and the appointments by the Management Board shall be made on the basis of the following criteria:

(d)

The nominations by the Member States, the selection by the Executive Director and the appointments by the Management Board shall be made on the basis of the following criteria:

(e)

The Management Board shall ensure that the broadest possible geographical distribution is achieved in the final appointments.

(e)

The Management Board shall ensure that the broadest possible geographical distribution is achieved in the final appointments.

(b)

The number of members in each Scientific Panel within the maximum provided for in paragraph 5f .

(ca)

In Article 28(9), the following point is added:

(a)

agendas and minutes of the Scientific Committee and the Scientific Panels and their Working Groups;

(a)

agendas, participants lists, and minutes of the Management Board, the Advisory Committee, the Scientific Committee and the Scientific Panels and their Working Groups;

(c)

scientific data, studies and other information supporting applications for authorisation under Union food law, 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 protection of confidential information and protection of personal data in accordance with Articles 39 to 39f.

(c)

scientific data, studies and other information supporting applications for authorisation under Union food law, 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 overriding public interest in disclosure and the protection of confidential information and protection of personal data in accordance with Articles 39 to 39f.

(d)

the information on which its scientific outputs, including scientific opinions are based, taking into account protection of confidential data and protection of personal data in accordance with Articles 39 to 39f;

(d)

the information on which its scientific outputs, including scientific opinions are based, taking into account the overriding public interest in disclosure and the protection of confidential data and protection of personal data in accordance with Articles 39 to 39f;

(ha)

information on the name of the applicant and the title of the application;

(i)

advice provided by the Authority to potential applicants at pre-submission phase pursuant to Article 32a and 32c.

(i)

the general advice provided by the Authority to potential applicants at pre-submission phase pursuant to Articles 32a and 32c.

(a)

to any intellectual property right which may exist over documents or their content; and,

(ca)

the following paragraph is added:

(1)

the method and other technical and industrial specifications relating to that method, used to manufacture or produce the subject matter of the request for a scientific output, including a scientific opinion;

(1)

the method and other technical and industrial specifications relating to that method, used to manufacture or produce the subject matter of the request for a scientific output, including a scientific opinion , except when relevant to understanding the potential effects on health and the environment, and provided that the applicant demonstrates with verifiable justification that such method does not entail information about emissions in the environment and about impacts on health and environment ;

(3)

commercial information revealing sourcing, market shares or business strategy of the applicant; and

(3)

commercial information revealing sourcing, innovative ideas for the product/substance, market shares or business strategy of the applicant;

(4)

quantitative composition of the subject matter of the request for a scientific output, including a scientific opinion.

(4)

quantitative composition of the subject matter of the request for a scientific output, including a scientific opinion , except when relevant to understanding the potential effects on health and the environment .

(a)

Where urgent action is essential to protect public health, animal health or the environment, such as in emergency situations, the Authority may disclose the information referred to paragraphs 2 and 3; and ,

(a)

Where urgent action is essential to protect public health, animal health or the environment, such as in emergency situations, the Authority may disclose the information referred to paragraphs 2 and 3; or ,

(b)

information which forms part of conclusions of scientific outputs, including scientific opinions, delivered by the Authority and which relate to foreseeable health effects.

(b)

information which forms part of conclusions of scientific outputs, including scientific opinions, delivered by the Authority and which relate to foreseeable effects on public health, animal health and the environment.

(ba)

where an overriding public interest in disclosure exists.

(bb)

any information for which there is an overriding public interest in disclosure under Article 4(2) of Regulation (EC) No 1049/2001 and Article 6 of Regulation (EC) No 1367/2006, in particular where the information relates to emissions into the environment.

(a)

make public, without delay, the non-confidential version, as submitted by the applicant;

(a)

make public, without delay, the non-confidential version of the application , as submitted by the applicant , once that application has been considered admissible ;

(c)

inform the applicant in writing of its intention to disclose information and the reasons for it, before the Authority formally takes a decision on the confidentiality request. If the applicant disagrees with the assessment of the Authority it may state its views or withdraw its application within two weeks from the date on which it was notified of the Authority’s position.

(c)

inform the applicant in writing of its intention to disclose information and the reasons for it, before the Authority formally takes a decision on the confidentiality request. If the applicant objects to the assessment of the Authority it may (1) state its views , (2) withdraw its application , or (3) request a review to the Authority’s Board of Appeal within four weeks from the date on which it was notified of the Authority’s position. The applicant may provide written notice to the Authority that it wishes to request a re-examination of the opinion to the Authority’s Board of Appeal. In that case, the applicant shall forward to the Authority the detailed grounds for the request within 60 days after receipt of the opinion. Within 60 days after receipt of the grounds for the request, the Authority’s Board of Appeal shall re-examine its opinion;

(d)

adopt a reasoned decision on the confidentiality request taking into account the observations of the applicant within ten weeks from the date of receipt of the confidentiality request with respect to applications for authorisation and without undue delay in the case of supplementary data and information and notify the applicant and inform the Commission and the Member States, as appropriate , of its decision; and,

(d)

adopt a reasoned decision on the confidentiality request taking into account the observations of the applicant within eight weeks from the date of receipt of the confidentiality request with respect to applications for authorisation and without undue delay in the case of supplementary data and information and notify the applicant and inform the Commission and the Member States, in every case , of its decision; and,

(e)

make public any additional data and information for which the confidentiality request has not been accepted as justified not earlier than two weeks after the notification of its decision to the applicant has taken place, pursuant to point (d).

(e)

publish non-confidential data and information relating to the application only once a final decision has been taken in respect of the confidentiality request pursuant to this Article and the Authority has published its draft scientific opinion in line with Article 38. Where an applicant withdraws the application pursuant to Article 39(c) because the applicant deems the publication of the information planned by the Authority to be too comprehensive, the Authority, the Commission and the Member States shall refrain from publishing any information on the application for authorisation .

(c)

the names of all participants in meetings of the Scientific Committee and the Scientific Panels and their Working Groups.

(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 .

(9b)

(2a)

(1a)

(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) 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.

(2a)

(b)

the trademark under which the substance, shall be marketed as well as the tradename of the preparations, material or articles in which it shall be used, where applicable; and,

(4a)

(a)

at an early stage of the risk management process, any envisaged the draft risk management measures;

(b)

the agendas and proceedings, detailed summary reports of meetings, and the draft measures, to be adopted, as appropriate, in the form of delegated or implementing acts, including the results and explanations of votes by individual Member States in committees within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council  (1a) , including the appeal committees, which assist the Commission in the implementation of [Regulation (EC) No 178/2002, Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1831/2003, Regulation (EC) No 2065/2003, Regulation (EC) No 1935/2004, Regulation (EC) No 1331/2008, Regulation (EC) No 1107/2009 and Regulation No 2015/2283], where and in which the risk management measures are discussed and put to a vote; and

(c)

the agendas and the detailed minutes of meetings of the Member States working groups in which the risk management measures are discussed.

(a)

the reasons for and objectives of the measure;

(b)

the justification of the measure taking into consideration both need and proportionality;

(c)

the impact of the measure on public and animal health, the environment, on the society and on food manufacturers as indicated by the impact assessment; and

(d)

the results of any public consultation, including pursuant to Article 9 of [the GFL Regulation].