New legislation on transparency and sustainability of the EU risk assessment model in the food chain

strawberry

(Danielle MacInnes, Unsplash)

This article is brought to you in association with the European Commission.


Yesterday, following the approval by the European Parliament on 17 April 2019, the Council has formally adopted a new Regulation on the transparency and sustainability of the EU risk assessment in the food chain. This new Regulation is based on aEuropean Commission’s proposal tabled in April 2018 and mainly amends the General Food Law Regulation[1]. It aims at increasing the transparency of the EU risk assessment in the food chain, on strengthening the reliability, objectivity and independence of the studies used by European Food Safety Authority (EFSA), and revisiting the governance of EFSA in order to ensure its long-term sustainability.It is a direct response to a successful European Citizens’ Initiative and builds upon the findings of the fitness check of the General Food Law Regulation , a comprehensive evaluation, completed in January 2018.

 

Which EU legal acts are concerned by the adopted legislation?

It covers the review of the General Food Law Regulation and the amendment of eight legislative acts dealing with specific sectors of the food chain:GMOs (cultivation and for Food/Feed uses), feed additives, smoke flavourings, food contact materials, food additives, food enzymes and flavourings, plant protection products and novel foods[2].

 

Once the new Regulation applies, how will the transparency of the EU risk assessment and the independence of scientific studies be increased?

The Regulation stipulates that all studies and information supporting a request for a scientific output by EFSA are to be made public automatically when an application is validated or found admissible. This will be done at the very early stage of the risk assessment process, in an easily accessible electronic format with the possibility to search, download and print the studies. Confidential information will be protected in duly justified circumstances. Confidentiality claims will be assessed by EFSA.

Other measures which will also ensure a more robust, independent and transparent risk assessment process are:

  • A notification obligation for applicants and laboratories when studies are commissioned and creation of a database of commissioned studies: This will provide a mechanism by which EFSA will be able to double-check whether all studies commissioned by an applicant in the context of its application for an authorisation, have been submitted;
  • Consultation of stakeholders and of the general public on submitted studies to ensure EFSA’s comprehensive access to existing evidence underpinning its risk assessment;
  • A specific procedure, including consultation of stakeholders and the general public on planned studies in the case of renewals of already authorised substances (see below);  
  • Pre-submission advice on the applicable rules and the required content of an application dossier, to be provided by EFSA upon request to potential applicants;
  • Fact-finding missions by the Commission to ensure the compliance of laboratories/studies with standards; 
  • Possibility for the Commission to ask EFSA to commission studies in exceptional circumstances to verify evidence used in its risk assessment process.

 

Intellectual property rights, data exclusivity and data protection will be guaranteed in line with the existing Union and national rules concerning intellectual property rights, which set out limitations on certain uses of the publicly disclosed documents or their content. EFSA will ensure that clear undertakings or signed statements are obtained to that effect, prior to disclosure of documents, without, however, jeopardizing the proactive character of, or the easy access to the disclosed information.

 

Are sanctions or penalties foreseen for non-compliant studies?

The legislation must be enforceable, therefore negative temporary stop in the risk assessment are foreseen to sanction applicants who have not complied with the notification obligation of commissioned studies.

 

Do these changes concern also the procedure for the renewal of already authorised substances?

Yes.

The changes will affect the renewals of authorisations of substances that are already on the market. The applicant will have to notify EFSA in advance the studies it plans to carry out for the renewal request along with the proposed study design. EFSA will then launch a consultation of third parties regarding these planned studies, and will be able to provide tailor-made advice to the applicant on the content of the renewal dossier as well as on the design of the studies.

 

Will confidential information be disclosed?

No, as long as this is duly justified. Applicants will have to provide verifiable justification for their possible confidentiality claims, based on the positive lists of confidential items, on the acceptance of which EFSA will decide.

 

How will the studies be disclosed and how will confidential information be processed in practice?

When the applicant submits a dossier, it may request certain parts of the submitted studies and other information (that are included in the positive lists of confidential items) to be kept confidential, with the condition that verifiable justification for this request is provided demonstrating that disclosure of the relevant information would potentially harm its interests to a significant degree. To this end, it should submit a non-confidential version and a confidential version of the submitted studies and other information.

When the application is validated or found admissible, EFSA will make the non-confidential version, as submitted by the application, of the submitted studies and information public. In parallel, within 10 weeks from the date of receipt, EFSA would assess the confidentiality claim. Once this assessment is completed, any additional data and information for which confidentiality requests has been considered as unjustified would also be made public.

 

Does the proposal protect personal data?

Yes.

Any processing of personal data would be carried out in accordance with the applicable Union legislative framework. On this basis, no personal data will be made publicly available unless it is necessary and proportionate for the purposes of ensuring the transparency, independence and the reliability of the risk assessment process, and preventing conflicts of interests.

 

Is the agreement reinforcing EFSA?

Since it is crucial to strengthen the EU risk assessment model which includes EFSA but also EU national scientific bodies contributing to EFSA’s work, the text agreed yesterday will lead to greater transparency of the risk assessment process by:

o   contributing to EFSA acquiring greater legitimacy in pursuing its mission and

o   increasing citizens’ confidence in EFSA’s work.

The EFSA model, as it is also the case for the other EU scientific agencies (EMAECHA), is dependent on its capacity to pool expertise from Member States. In particular, national scientific organisations contribute to EFSA’s work by allowing their experts to work in EFSA as experts in its Scientific Panels and by providing EFSA with scientific data and studies. These contributions should be further supported to avoid increasing current difficulties in attracting sufficient candidates for EFSA’s Scientific Panels.

The Regulation addresses these limitations by reinforcing EFSA’s own scientific capacity and by strengthening the scientific cooperation with national scientific organisations.

The key elements concern:

– Independence

EFSA will remain independent. EFSA is a European agency funded by the European Union that operates independently of the European legislative and executive institutions (i.e. Commission, Council, and European Parliament) as well as the Member States. The rules whereby members of the Management Board and members of the Panels have to act independently and – publicly – make an annual declaration of interest are maintained and reinforced. EFSA Management Board will also continue to hold its meetings in public.

– Role of Member States

Each Member State will nominate a representative to the Management Board, thus taking more responsibility for supporting EFSA and ensuring an increased scientific cooperation. Member States’ representatives in the new Management Board will be required to meet specific requirements and will be selected on the basis of their relevant experience and expertise in the field of the food chain legislation and policy, including risk assessment. Strict criteria of independence will have to be fulfilled.

 

What has been agreed on risk communication?

Ensuring a coherent communication throughout the risk assessment process is key for two reasons. First, it enables to avoid divergences that could have an adverse impact on public perception as regards safety in the agri-food chain. Second, it guarantees a more comprehensive and continuous process throughout the risk analysis process, by actively involving all the relevant parties (i.e. the Commission, EFSA, Members States, stakeholders and the public). Both elements are very relevant for European citizens.

To this end, the new Regulation sets out objectives and general principles of risk communication. Based on these objectives and general principles, the Commission is empowered to set out a general plan on risk communication by means of an implementing act, to promote an integrated risk communication framework for all risk assessors and risk managers on all matters relating to the food chain.

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, (e.g. different level of risks, nature of risk, risk perceptions etc.);
  • determine the tools and channels to be used as well as the appropriate mechanisms of coordination and cooperation between the risk assessors and risk mangers; and,
  • launch an open dialogue amongst all interested parties.

 

What is next?

The new Regulation is expected to be published in the Official Journal on 6 September 2019. Following its entry into force 20 days after publication, it will become applicable 18 months later (by end of March 2021).

The Commission and EFSA will work closely to ensure the proper implementation of the new Regulation.

Advertising

the sting Milestone

Featured Stings

Can we feed everyone without unleashing disaster? Read on

These campaigners want to give a quarter of the UK back to nature

How to build a more resilient and inclusive global system

Stopping antimicrobial resistance would cost just USD 2 per person a year

70 years on, landmark UN human rights document as important as ever

Eurobarometer: Not a single answer about what the Banking Union will cost to citizens

AI-powered automation will have an ethnic bias

Canada has created an Arctic conservation zone almost as big as Germany

Future EU-UK Partnership: European Commission publishes draft legal text

Ukraine pays the price for lying between Russia and the EU

Bankruptcy or referendum: which one is going to be first?

EU Justice Scoreboard 2019: results show the continuing need to protect judicial independence

European Fund for Transition to support more workers made redundant

Africa is launching the world’s largest free trade area – but these are the stumbling blocks

Nearly a third of the globe is now on Facebook – chart of the day

Our global system has spun out of control. Here’s how to rebalance it

UN General Assembly celebrates 20 years of promoting a culture of peace

G20 World Exclusive Interview: “The world, especially emerging economies and developing countries, require a more sustainable and quality development”, the Spokesperson of Japan underscores live from Antalya Turkey

Regional competitiveness and growth: a Gordian knot for Europe

An economist explains why women are paid less

UN Member States overwhelmingly support end of US embargo against Cuba

LGBTQI+ and health care: do they deserve more attention from medical universities?

What little Cameron got in Brussels seems enough to keep Britain in the EU

G20 LIVE: “United States and Turkey stand in solidarity with France and its people in handing the perpetrators of this crime and bringing them to justice”, US President Barack Obama underlines from G20 in Antalya Turkey

Coronavirus: 5 ways to work from home with your kids (and stay sane)

Global climate change: consequences for human health in Brazilian cities

Courage of terrorism survivors underlines ‘urgency’ of UN Investigative Team’s work in Iraq

End fossil fuel subsidies, and stop using taxpayers’ money to destroy the world: Guterres

#Travelgoals: why Instagram is key to understanding millennial tourism

The rise of techno-nationalism – and the paradox at its core

EU-Turkey leaders’ meeting, 9 March 2020

Burundi: Inclusive dialogue ‘only viable option’ for resolving country’s political crisis says, UN envoy

45th Anniversary of the French Confederation (Confédération Nationale des Junior Entreprises)

Syrian civilians must be protected amid ISIL executions and airstrikes: Bachelet

Privacy is a human right, we need a GDPR for the world: Microsoft CEO

Multilateralism: The only path to address the world’s troubles, signals Guterres

Syria: UN health agency highlights ‘critical health threats’ facing Idlib civilians

China’s lead in the global solar race – at a glance

Sustainability, peace, security ‘best guarantee against instability’ Guterres to Security Council

OECD Donor countries need to reform development finance to meet 2030 pledge

Four in five adolescents failing to exercise for even 60 minutes a day, UN health agency warns

World Population Day: ‘A matter of human rights’ says UN

UNcomplicating the UN: a new podcast is born over coffee in New York

Commission Vice-President Rehn exaggerates Eurozone’s growth prospects

An expert explains: the digital risks facing our children during COVID-19

How will EU look after French, Dutch and German Elections and what will be the implications for Youth Entrepreneurship?

EU plans pan-European network of cybersecurity services

Thousands of Syrians in ‘life and death’ struggle amid harsh conditions in remote desert camp, UN warns

Tuesday’s Daily Brief: #GlobalGoals progress, essential meds, updates from Cox’s Bazar, Sudan and DR Congo

Lagarde: Keep feeding the banks cut down wages and food subsidies

Crime and drugs in West and Central Africa: Security Council highlights ‘new alarming trends’

Country origin ‘best predictor of outcome’ for children with cancer, UN experts say

‘Reaffirm the sanctity’ of religious sites, says Guterres, launching new plan to ‘counter hate and violence’

4 key steps towards a circular economy

Cameron postpones speech in Holland

How to help companies become global defenders of LGBTI rights

How COVID-19 could open the door for driverless deliveries

Migration crisis update: What are the chances of a fair deal at this EU Summit?

Boosting adult learning essential to help people adapt to future of work

Here’s how to make ‘value-based healthcare’ a reality

Action needed to end deadly clashes between African herders and farmers: UN chief

The IMF overstates the risks for Eurozone and downgrades the threats for the US economy

UN working with both sides, after hidden tunnels confirmed along Lebanon-Israel ‘Blue Line’

More Stings?

Advertising

Speak your Mind Here

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s