Articles / The European Transparency Regulation: Framework for Risk Assessment and Food Safety

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The European Transparency Regulation: Framework for Risk Assessment and Food Safety (2022)

On 27 March 2021, the Transparency Regulation was born and became applicable by the European Parliament and the Council. The Regulation aims to improve transparency and sustainability in food chain risk assessment in the European Union.

This Regulation introduced many changes with various implications for businesses, national health agencies, and civil society representatives.

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Transparency and Sustainability of the EU risk assessment in the food chain

On 13th of June 2019, The Council of Europe adopted a new regulation on the transparency and sustainability of the EU risk assesment in the foodchain (link). It amends the General Food Law Regulation and aims at improving transparency of EU risk assessment in the foodchain in order to ensure long-term sustainability.

The new transparency regulation was published in the official journal on 6th of September, 2019, and was enforced twenty days after publication. It was finally applicable on 27th of March, 2021.

The EU Comission and EFSA cooperate to safe guard the implementation of the new regulation. You can read more about the implementation.

Why the Change in the Transparency Regulation?

Regulation (EU) 2019/1381 increases the dependability, objectivity, and independence of the studies utilized by the European Food Safety Authority (EFSA) and the transparency of EU risk assessment in the food chain. It reinforces EFSA’s governance; each member state had a representative on its management board by July 2022.

Transparency Regulation adjusted the regulatory framework that existed according to the proposal by the European Union of April 2018 and eight legislative acts in sectors, including:

    • Novel foods
    • Genetically modified organisms
    • Food contact materials
    • Plant protection products
    • Feed additives
    • Food additives, flavorings, and enzymes
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Background: EU’s “farm to fork” approach

By 1990, especially after the mad-cow crisis, there was a need to improve food and feed safety in the EU. The European Commission spearheaded the campaign for a “farm to fork” approach.

Regulation (EC) No 178/2002 brought forward general principles and requirements regarding food law. It also established EFSA and laid down procedures concerned with food safety.

The Commission initiated an improvement program as part of its “smart regulation” policy focusing on the General Food Law Regulation (GFLR). By 2002 June 2019, the European Parliament and the Council adopted Regulation (EU) 2019/1381, which improves on the GFLR, whose audit was completed by January 2018. This was a follow-up on an initiative by European citizens regarding pesticides.

Key Objectives of the Regulation

The Regulation amends the GFLR and eight other acts regarding particular food chain sectors highlighted above. Its four key objectives include:

Improved Transparency

The first objective is to ensure improved transparency for risk assessment in the food chain. Consumers would access scientific studies and information available at EFSA. This is from the industry before embarking on the risk assessment process. The Regulation emphasized the protection of confidential information justified after a risk assessment by EFSA.

Increased Independence of Scientific Research

According to the Regulation, EFSA should be informed of all industry-commissioned studies undertaken by laboratories. Businesses are obliged to submit all relevant information before applying for authorization. The requirement would enable EFSA to establish a single database for European-commissioned studies.

It also provides a platform where companies can get advice from EFSA regarding scientific research before submitting applications or notifications. The Regulation powers the European Commission to authorize EFSA to oversee additional research to verify evidence during risk assessment performance. Additionally, EFSA would ensure laboratory compliance with applicable standards.

Enhanced Governance of Scientific Cooperation

The Regulation mandated member states to have representatives on EFSA’s management board. All member states got an opportunity to enhance the organization’s scientific capacity organization the best experts in its work.

Developing Comprehensive Risk Communication

There was the adoption of a general plan for risk communication to guarantee the effective exchange of information through a risk assessment process. Effective risk communication depends on open dialogue among all interested parties.

Impacts of the Regulation on Risk Assessment and Independent Scientific Research

Let’s examine how the regulation enhances risk assessment and independence in scientific studies.

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Access to scientific studies and information

Understanding the Transparency Regulations regarding the framework for risk assessment and food safety is very important for any business owner, laboratory, or testing facility.

Understanding any changes to the framework, how to comply, and the procedures to follow is essential.

The new Regulation allows citizens access to scientific research and information available at EFSA from the industry. It means easy access to information and studies in the electronic format right from the beginning of the risk assessment process. The studies are to be available to search through, download, or print. Access to confidential information would be authorized by EFSA and duly protected.

Public consultations in assessing applications for authorization

According to the Regulation, the public consults while assessing authorization applications for regulated products. Consulting stakeholders and the public regarding submitted studies give EFSA access to available evidence while conducting a risk assessment. A consultation procedure is available for renewal applications regarding authorized substances.

Knowledge of all commissioned studies

The Regulation gives EFSA access to all commissioned studies in the industry and by laboratories. Businesses applying for authorization must submit all relevant details. The European Commission gets the power to authorize EFSA to oversee further studies to prove evidence used in the risk assessment process.

Modiefies EFSA Governance

Adding representatives from member states to the management board modified EFSA’s governance. Efforts are in place to enhance participation from member states while drafting the organization’s opinions. Everyone will easily access information regarding risk assessment and managing food-related risks.

What is pre-submission advice?

The Regulation offers a platform for companies to get scientific advice from EFSA before submitting their application and notification. EFSA staff involved in the pre-submission advice must not participate in any scientific or technical work connected to the application.

EFSA’s database for commissioned studies

Under the new regulations, EFSA must establish and operate a database for recording commissioned studies or those carried out by companies to support their application or notifications.

All businesses must notify EFSA without delay about the title and scope of the study they’re carrying out. The business must also share details about the laboratory or testing facility undertaking the study in question, including its start and end date.

The same provision requires laboratories and testing facilities in the EU to notify EFSA of the information and name of the client commissioning the study. Disclosure obligations in Article 32b also apply to laboratories in third-world countries if agreements and arrangements exist with that particular country.

How public consulations are conducted

Article 32c of the Regulation mandates third parties, including the public and stakeholders, to participate in consultations when AFSA receives applications regarding commissioned studies for authorization or renewal. The consultation covers comprehensive studies for renewal and must include the proposed design.

Consultation is based on a non-confidential version of the application or notification. It aims to identify other relevant scientific data or research on the subject matter on which the application or notification is focused. Comments are made after the consultation, and then EFSA advises on the content for the intended application or renewal and study design.

What is the verification process of these studies?

The new Regulation allows the Commission to have EFSA undertake its study to verify the risk assessment process during serious controversy or conflicting results. This is because the commissioned studies may have a broader scope than the evidence presented for verification.

Undertaking its verification of the study extends the approval or authorization timeline from EFSA. Applicants can’t control the process of conducting and designing the verification. Situations when FSA may resort to this measure are very controversial.

EFSA’s Role

The European Food Safety Authority offers independent advice on food-related risks. This organization advises on existing and emerging food risks. Advice from EFSA determines making European laws, policy-making, and rules and protects consumers from risks in the food chain.

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