Opinion of the European Committee of the Regions — Risk assessment in the food chain

(2018/C 461/19)

Rapporteur-general:	Miloslav REPASKÝ (SK/EA), Member of the regional parliament of the PrešovSelf-Governing Region
Reference document:	COM(2018) 179 final

I. RECOMMENDATIONS FOR AMENDMENTS

Amendment 1

Recital 4 of the proposal for a regulation

Text proposed by the European Commission

CoR amendment

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.

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 , including consumers and consumer organisations, to ensure the prevalence of public interest, the coherence and consistency within the risk analysis process.

Amendment 2

Recital 8 of the proposal for a regulation.

Text proposed by the Commission

CoR amendment

(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 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 , the uncertainties detected in risk assessment, 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 at all levels of government, including at the level of regional and local authorities .

Reason

A substantial proportion of European legislation is implemented by local and regional authorities, and it is therefore essential that these bodies are properly involved in the implementation of the communication strategy, as well as to ensure that this strategy is coherent.

Amendment 3

New Article 8a of Regulation (EC) No 178/2002

Text proposed by the Commission

CoR amendment

Objectives of risk communication

Risk communication shall pursue the following objectives, while taking into account the respective roles of risk assessors and risk managers:

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

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

b)	promote consistency and transparency in formulating risk management recommendations;

b)	promote consistency and transparency in formulating risk management recommendations with the aim of reaching a high level of protection of nature, human health, animals and the environment ;

c)	provide a sound basis for understanding risk management decisions;

c)	provide a sound basis for understanding risk management decisions;

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

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

e)	promote appropriate involvement of all interested parties; and,

e)	ensure that the public’s awareness of the concepts of ‘danger’ and ‘risk’ are understood and that different trade-offs between risks and benefits are accepted;

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

f)	promote appropriate involvement of all interested parties; and strengthen relations and mutual respect between them and,

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

Reason

Given the different approaches to understanding the concepts of risk and hazard in the Member States and the related debate between policy makers, academics, regulators and the industry, it is worth highlighting the importance of raising public awareness of these concepts and ensuring that the public understands and accepts the trade-offs between risks and benefits.

Amendment 4

New Article 8c of Regulation (EC) No 178/2002

Text proposed by the Commission

CoR amendment

General plan for risk communication

1. The Commission, in close cooperation with the Authority, the Member States and following appropriate public consultations shall be empowered to adopt delegated acts in accordance with Article 57a establishing a general plan for risk communication on matters relating to the agri-food chain, taking into account the relevant objectives and general principles set out in Articles 8a and 8b.

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 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 needs of relevant target audience groups; and,

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 and ensure an open dialogue amongst all interested parties.

3. The Commission shall adopt the general plan for risk communication within [two years from the date of application of this Regulation] and shall keep it updated, taking into account technical and scientific progress and experience gained.’;

Reason

Same as for amendment 1.

Amendment 5

Article 39.2.1

Text proposed by the European Commission

CoR amendment

‘Article 39

Confidentiality

[…]

(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 , provided that the applicant demonstrates that such method has no harmful impacts on health and environment ;

[…]

Reason

The amendment aims at giving better consideration to health and environmental protection.

Amendment 6

Article 39.4.b

Text proposed by the European Commission

CoR amendment

‘Article 39

Confidentiality

[…]

4. Notwithstanding paragraphs 2 and 3, the following information shall nevertheless be made public:

[…]

(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 potential human or animal health or environmental effects.’;

Reason

The amendment aims at giving better consideration to health and environmental protection.

II. POLICY RECOMMENDATIONS

THE EUROPEAN COMMITTEE OF THE REGIONS

Background

welcomes the Commission’s initiative aimed at increasing the transparency and sustainability of EU risk assessment in the food chain as a move in the right direction that clarifies the transparency rules particularly regarding the scientific studies used by EFSA in its risk assessments, improves EFSA management, bolsters scientific collaboration between the Member States and EFSA and their involvement in EFSA’s scientific work and develops a comprehensive and effective communication strategy in the field of risk;

believes that this initiative is a move in the right direction but doubts persist about whether the proposed changes will enable an independent scientific scrutiny of studies and data used in the risk assessments of regulated products and substances due to the current legal framework on data protection and confidentiality rules;

notes that this legislative proposal responds to the findings of the fitness check carried out by the Commission of Regulation (EC) No 178/2002 on food law (1), as well as to the European Citizens’ Initiative ‘Ban glyphosate and protect people and the environment from toxic pesticides’, and amends several sector-specific laws;

points out that the fitness check for Regulation (EC) No 178/2002 revealed that people are calling for a more transparent risk assessment procedure in the area of food law, as well as a more transparent decision-making process based on risk assessment. The conclusions of the fitness check also identified other areas where change is needed, namely EFSA’s management (negative signals regarding its ability to maintain the high quality and independence of scientific studies and the need to strengthen cooperation with all Member States), and the lack of communication about risk more generally;

points out that risk assessment is carried out at EU level by EFSA, which was set up by the GFL Regulation. EFSA is an independent scientific body responsible for carrying out expert assessments of aspects relating to the safety of EU food and animal feed at the request of the Commission, the Member States and the European Parliament, as well as on its own initiative. These risk assessments are carried out separately from risk management, for which the European Commission is largely responsible;

Transparency, independence and reliability of the EU risk assessment process

highlights the fact that citizens and other stakeholders have raised concerns about the transparency and independence of industry generated studies and data used by EFSA in its risk assessments in the context of authorisation procedures for regulated products or substances;

acknowledges that the Commission’s proposal complies with the principles of subsidiarity and proportionality;

observes that the current authorisation process is based on the applicant (industry) directly commissioning the studies required for application dossiers. Central to this concept is the idea that public money should not be used to commission studies that will eventually help industry to put a product on the market;

points out that as a result of the above, intellectual property rights over the studies and their content used in risk assessments lie within the industry, and thus an independent scientific scrutiny might not be possible considering the wording of the new paragraph 1a of Article 38 of the GFL Regulation, which states that ‘the disclosure to the public of the information mentioned in paragraph (1)(c) shall not be considered as an explicit or implicit permission or license for the relevant data and information and their content to be used, reproduced, or otherwise exploited’;

10.

notes that if independent researchers are not able to publish their findings, there will be no incentives for them to cross-check the results of a study used in the EFSA risk assessments;

11.

notes that for independent researchers to be able to form a judgement about the validity of an analysis and to reproduce the findings of a study or make additional discoveries, it is fundamental to have access not only to data but also to the software used to obtain the results. It would be therefore very useful to clarify the position of the Commission and EFSA as far as access to the proprietary software used in sponsored studies is concerned, not least in view of EFSA’s proclaimed aim of making its scientific output reproducible;

12.

also notes that experience has shown that public access to information and data, which would make it possible to check the correctness of the safety assessment of a substance, may not be straightforward and can involve the intervention of the EU courts (2);

13.

notes in this context that Article 12 of Regulation (EC) No 1049/2001 on Public Access to European Parliament, Council and Commission documents allows for, and indeed encourages, proactive publication; it takes the view that the EU rules on public access to information should be applied in a coherent way by all EU scientific advisory bodies and their proactive disclosure policy should be coherent to guarantee predictability;

14.

in this context notes that the European Medicines Agency, under its Policy 0070 aimed at enabling public scrutiny and application of new knowledge in future research in the interest of public health (3), published in 2016 a guidance document on the Agency’s proactive disclosure policy for clinical data;

15.

supports the proposal to set up a register of all studies managed by EFSA which should make publication bias and withholding of important safety information more difficult; notes that such an EU register is already in place for clinical trials (4);

16.

with regard to assessing the confidentiality of data, feels that harmonisation is important and therefore does not consider the passing of this obligation on to the Member States to be the best solution. The confidentiality of the data should be decided by EFSA, thus ensuring a unified approach to assessing applications on this sensitive issue;

Sustainability of the EU risk assessment procedure and EFSA management

17.

welcomes the fact that one of the aims of this legislative proposal is to improve the management of EFSA, strengthen Member States’ scientific cooperation with this body, and increase their participation in its scientific work;

18.

welcomes the considerable increase in EFSA’s budget, enabling it to perform its newly assigned tasks, such as commissioning independent safety tests in exceptional circumstances, while pointing out that sufficient funding must be guaranteed for the EFSA to be able to carry out its core tasks without constraints;

19.

welcomes the alignment of the membership of EFSA’s management board and the procedure for the external assessment of EFSA set out in the annex to the 2012 inter-institutional joint statement on Union decentralised agencies;

20.

notes that at present there are 14 elected members of the EFSA board, which is expected to rise to 35 under the present proposal. Each Member State should nominate its own representative and alternate, thereby ensuring greater involvement on the part of the Member States in the management of EFSA. The Commission nominates two members and the European Parliament has one representative; four members will represent the interests of civil society and the food chain;

21.

observes that, in the event of inadequate staffing capacity, especially with regard to smaller Member States (up to 12 national experts per Member State will need to be appointed), the proposal allows for the possibility of appointing experts from other Member States to EFSA panels; this would however undermine the targeted balance of cooperation among all Member States;

Better communication about risk

22.

welcomes the fact that the general plan on risk communication, as set out in the Commission’s proposal, takes into account risk perceptions and stresses in this regard that it is very important to raise awareness among the general public about concepts such as ‘danger’ and ‘risk’;

23.

observes that despite the uniform principles for evaluation and authorisation of regulated products, inconsistencies are apparent across Member States in relation to the regulation of certain substances, which may arise from different approaches to the concepts of hazard and risk and social acceptance of the level of risk involved;

24.

highlights the general decline in trust in policymakers in Europe and points out that public trust is one of the most important explanatory variables of the public’s perceptions of risk (5). If the public trusts policymakers or regulators, they will perceive risks to be less than when they do not trust them;

25.

therefore supports the notion of raising the confidence of the public and interested parties in the transparency and sustainability of the EU’s approach to food safety, especially in relation to risk assessment, maintaining at the same time that for a risk communication strategy to be effective it is necessary to engage with the public and other relevant stakeholders in a proactive and productive way, making sure that different trade-offs between risks and benefits are understood and accepted;

26.

stresses that the EU risk communication strategy must be inclusive and must ensure that all levels of government, from the level of central government to that of local and regional authorities, as well as other relevant players, are duly involved to guarantee a coherent risk communication strategy addressing risks associated with the food chain;

27.

points out that, on the basis of the analysis and discussion of the proposal to date, account must be taken of the expected increased administrative burdens, greater demands on national experts in the context of their membership of the EFSA board and their activities on EFSA scientific panels, possible political influence on the nomination of national experts, with a resulting impact on EFSA’s independence, and a significant financial impact on all Member States as a result of a considerable increase in EFSA’s budget, as well as in view of the anticipated budgetary consequences of Brexit.

Brussels, 10 October 2018.

The President of the European Committee of the Regions

Karl-Heinz LAMBERTZ

(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.

(2) Hautala and Others v EFSA (case T-329/17), action brought on 24 May 2017.

(3) http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf

(4) European Clinical Trials Database (EudraCT) managed by the European Medicines Agencies.

(5) From research carried out by Ragnar Löfstedt and other researchers in the field of risk communication and management.