The revised EU GFL (Reg (EC) 2019/1381), or transparency regulation, comes into force on 27 March 2021 and sees changes in the notification of studies, submission of dossiers via IUCLID and the publication of all study reports, to name a few. Read on to find out how these changes may impact you.
General Food Law in the EU: revisions strengthening transparency
The massive Europe-wide public outcry over renewal of glyphosate was a key trigger for the European Commission (EC) to review the General Food Law (GFL), Regulation (EC) No 178/2002.
The European Citizens’ Initiative (ECI), which gathered over 1 million signatures supporting a ban on glyphosate, called for enhanced protection of humans and the environment from toxic pesticides and the setting of EU-wide mandatory reduction targets for pesticide use. In response, the EC undertook a fitness check of the GFL. The result was Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain. It is hoped this revised GFL legislation will guarantee the reliability, objectivity and independence of the studies used by EFSA in risk assessment and risk communication related to substances used in the production of food and feed.
The revisions to GFL legislation focus on four key areas:
- Greater transparency
- Increased independence of scientific studies
- Strengthened governance of EFSA and scientific cooperation
- More comprehensive and effective risk communication.
GFL revisions ensure greater transparency
At the heart of the GFL revisions is an increase in transparency designed to help build public trust in decision making on the chemicals that make it into the food chain. To this end, the public will be granted access to all studies and data submitted by the industry to EFSA at an early stage of the risk assessment process. Also, stakeholders and the public will be consulted on any submitted studies. From an industry perspective, this is generally welcome but not without some concerns regarding the release of sensitive information, as study confidentiality is guaranteed only in justified circumstances when there may be significant harm to commercial interests.
GFL revisions increase the independence of scientific studies
In order to overcome public suspicion that industry could ‘hide’ unfavorable data on their compounds, the GFL mandates that EFSA is pre-notified of all potential safety studies and the identity of the laboratories or testing facilities where studies will be conducted. This will allow EFSA to build a database of studies for tracking and will ensure those studies are subsequently submitted for review. In addition, it allows EFSA to check compliance standards of testing facilities to further reassure the public that high scientific standards are being met. In some exceptional circumstances, EFSA will be able to carry out its own studies. The situation is slightly different for new active substance submissions versus those undergoing renewal, as we shall see later.
GFL revisions strengthen governance and scientific cooperation
The GFL revisions also change governance in an attempt to enhance independence and ensure the best, multidisciplinary scientific and regulatory expertise is leveraged in decision making. This sees changes to the management board of EFSA to include representatives from all member states (MS). The EFSA scientific panels will also be better organized and will include experts nominated by MSs. Strict independence criteria will be implemented.
GFL revisions drive effective risk communication
The revisions to GFL improve coordination between risk assessors and risk managers to ensure better communication to stakeholders and the general public. Information should include a clear explanation of how any risk management decisions were reached.
What types of substances are affected by the revised GFL legislation?
Although concern over pesticide use was the key instigator of the revisions to GFL, the changes go wider than the active substances (a.s.) used for crop protection products (CPPs). In fact, a wide range of chemicals that may end up being consumed by animals or humans are impacted by GLF, including:
- GMOs in food and feed, e.g. GM soyabean in animal feed
- Food contact materials, e.g. adhesives or coatings on paper or board packaging
- Feed additives, e.g. coccidiostats and histomonostats used to control gut parasites
- Enzymes flavorings, e.g. naringinases are used in wine production to enhance aroma or to de-bitter grapefruit juice
- Smoke flavorings, i.e. complex mixtures used by the food industry.
The GFL regulatory framework in context
The GFL is the cornerstone of the EU regulatory framework covering the entire agri-food sector. It covers risk assessment, risk management and risk communication. Regulation (EU) 2019/1381 amends the original GFL (Reg (EC) No 178/2002) and a number of existing sector-specific regulations and directives.
The GFL revisions impact import tolerance and maximum residue level applications, and also both new approvals and renewals of active substances. As a result, there are amendments to the regulation governing the Annex I renewal (AIR) submission program. Regulation (EC) 844/2012 is being repealed and replaced by Regulation 2020/1740 (20/11/20). This regulation comes into force on 27 March 2021 (with the GFL) and applies to all active substances with expiry dates after 27 March 2024.
Putting the requirements of the Transparency Regulation into practice
EFSA has been charged with the responsibility for putting the necessary practical arrangements in place to ensure the provisions of the regulation are met. Some of the key provisions for crop protection applicants are:
- The process for notification of studies
- changes in dossier format and submission platform
- the process for publication of all study reports, not just summary dossiers.
In January 2021, EFSA published detailed arrangements for how the new rules and measures specified in the regulation will operate in practice. The Practical Arrangement (PAs) documents are claimed by EFSA to “help stakeholders to better understand how the new processes and tools affect them and what adjustments they need to make to operate effectively in the new environment.” The PAs cover areas such as processing of applications for access to documents, proactive transparency, confidentiality, notification of studies, pre-submission advice and consultation of third parties.
Notification of studies
Registrants must pre-notify EFSA of all commissioned studies supporting or expected to support an EU application and submit them with any subsequent authorization application. CROs (contract research organizations) in the EU will also be required to co-notify studies intended to be submitted for EU evaluation. It is now understood that following BREXIT CRO’s based in the UK will not be subject to the amendments to the GFL and will therefore not be obliged to co-notify studies. However, it is emphasized this does not impact applicant’s free choice to choose whatever laboratory they want globally to use for conducting their studies supporting an EU application. This could be in house laboratories or CRO’s.
Notification is not required for studies supporting a national /zonal PPP application unless they relate to a likely representative use to support a new a.s. or renewal application.
Notification of studies – active substance renewals (Article 32c)
For a.s. renewals, the process is slightly different. Initially, a list of intended studies will need to be submitted to EFSA, which has similar information as for pre-notification but without start and completion dates or the intended laboratory. However, applicants must include information on study design with their list of intended studies. EFSA will then launch a systematic public consultation on the intended studies and their proposed design. Public feedback will be used to help inform the EFSA’s decision making. EFSA will issue written advice on the planned studies and content of the dossier. It is at this point, if given the go ahead, that applicants notify and, if needed, EU based CROs co-notify, the studies including start and planned completion dates.
What happens if your dossier contains un-notified studies?
The expectation is that notified studies will be submitted in every application made for approval of a new a.s., renewal of an a.s. or application for a new or modification of an IT/MRL. If un-notified studies are included, then it is likely the application will be rejected.
Dossier format and submission using IUCLID
The format for producing dossiers and the platform for submitting them to EFSA are also changing for crop protection active substances. From 27 March 2021, dossiers must be prepared and submitted using IUCLID (International Uniform Chemical Information Database) software. IUCLID was developed jointly by the ECHA (European Chemicals Agency) and the OECD (Organisation for Economic Co-operation and Development). IUCLID has been used for many years for chemical and biocide notification in Europe under REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), BPR (Biocidal Product Regulation) and CLP (classification and labelling).
Publication of all study reports, not just summaries
From 27 March 2021, EFSA will publish all study reports and not just summary dossiers. Applicants, therefore, need to identify and seek EFSA approval for the redaction of confidential information that might, if disclosed, harm their interests significantly. Information currently placed in Document J of crop protection a.s. dossiers will remain confidential. To allow for this, two versions of the dossier will be submitted: one for the authorities and one redacted for use in the public domain. Redacted reports can be appended in IUCLID. Information that can be justified as confidential includes personal information like names, addresses, e-mail addresses, etc. and names of laboratories or animal suppliers involved in conducting vertebrate studies. Other information may be classed as confidential if it would undermine the protection of “commercial interests of a natural legal person, including intellectual property” (Regulation EC 1049/2001). The limited list provided in the legislation and the extent to which companies have to demonstrate potential commercial harm is causing great discussion and concern amongst stakeholders and this aspect of the law is sure to be tested in the coming months. Further there is concern amongst CROs about the legal agreements they have with their customers, with protection of their staff, intellectual property and commercial interests. Such concerns have not been addressed by EFSA or EU Commission.
Helping you navigate the GFL changes
New regulations or regulatory changes always present challenges when first introduced. Covance has a long history and proven track record of supporting partners through the evolving landscape of European and worldwide crop protection and chemical regulations. And we are here to help you this time too.
How is Covance getting prepared for the GFL revisions?
Covance by Labcorp is:
- Actively engaging with the EFSA Scientific Committee and other industry members to ensure rapid access to new information and a route for questions and clarification
- Keeping up to date by attending stakeholder webinars and training
- Listening to EU customers to establish and address priority concerns and needs
- Building a multidisciplinary team, internal structures and processes to allow Covance to support customers effectively. For example:
- Considering logistics and process needs for co-notifying of studies that are performed by Covance laboratories based in Europe (e,g. Residue field trials, occupational exposure studies and field dissipation studies)
- Exploring legal questions related to intellectual property, current non-disclosure and contractual agreements, implications linked to the global data-protection regulations
- Upskilling customers on the GFL and its implications through various media channels and tailored customer meetings.
- Developing an in-house standard operating procedure for the sanitization of reports to ensure compliance with the regulation
Leveraging in-house expertise and experience
Covance by Labcorp has been partnering companies submitting EU applications under REACH and BPR regulations for many years. This means we have vast experience in IUCLID dossier preparation and submission, as well as the creation of study information for public disclosure. Therefore, we have the necessary experience and insight to address the GFL changes in these areas. Covance by Labcorp has a presence in the U.S., UK, Europe, Japan and South Korea and is, therefore, well positioned to support EU applications.
The updated GFL is designed to provide EU citizens with greater confidence in the safety of chemicals that find their way into the food chain. This greater transparency and heightened scientific rigor should be welcomed, despite the increased administrative burden and responsibility it places on applicants and EU-based CROs. Ultimately, it is believed that the revised GFL will raise industry standards and the standards and accountability of decision making in risk assessment within EFSA. If you have any specific questions or would like to benefit from Covance by Labcorp insights and expertise regarding GFL, please contact us.