The EU General Food Law and the Transparency Regulation: FAQ’s with Mike Carroll
The EU General Food Law (GFL Regulation 178/2002) has been amended by the Transparency Regulation (Regulation 2019/1381) and is significant because of the impact on plant protection product regulations by changing the rules on confidential business information and trade secrets. It also puts major obligations on applicants to register new studies before they begin.
Companies have until 27 March 2021 to prepare and ensure that their plant protection products are compliant with the new legislation.
As we start 2020, we’ve taken the opportunity to catch up with Mike Carroll, Principal Consultant – Plant Protection Products, to find out more about the new regulation and what companies can do to ensure that they are GFL ready.
Why is the amended General Food Law such a significant piece of legislation?
MC: The amended General Food Law is a significant piece of food and feed law, ensuring that all European citizens have access to safe and wholesome food of the highest standards. It sets the rules in the EU for transparency and confidentiality and from March 2021, the complete reports of all scientific studies reviewed by EFSA (European Food Safety Authority) will be publicly available, unless EFSA grants confidential treatment in cases where an applicant can demonstrate that disclosing certain information will harm its commercial interests. In addition, the GFL impacts active substance renewals and new active substance approvals as applicants now need to notify EFSA in advance of the studies it plans to carry out for the renewal/application request, along with the proposed study design.
The modifications represent a major change to the way the EU treats trade secrets and could leave some companies in a vulnerable position as their trade secrets may no longer necessarily remain confidential.
What are the top 3 things companies can do to ensure they are compliant with the amended General Food Law?
MC: From my experience in the industry, I would say:
1) Start straight away – There’s no need to wait around for further guidance from EFSA or the European Commission on the process for study notification. Be proactive and notify EFSA of upcoming studies to avoid being in a situation where studies may not be considered in active substance renewals or new active substance approvals. Whilst EFSA say that the GFL is prospective, there may be certain circumstances in which dossiers are made publicly available retrospectively. It is therefore recommended to review previous dossiers to ensure they are GFL compliant, and take any action required.
2) Seek help from regulatory professionals – An easy way to get comprehensive advice and training is to sign up for our General Food Law Seminar on 18 February. We will be taking you through the General Food Law line by line and giving you advice to help ensure your business stays regulatory compliant.
3) Talk to your manufacturer – Companies need to look at the interface between registration and manufacturing and make sure everything lines up. It is important to have discussions with manufacturers to ensure companies can be GFL ready by early 2021.
In terms of confidential information, what does significant harm mean and how can companies demonstrate it?
MC: The industry has looked into this in some detail and of course trade secrets are intellectual property. If companies have used trade secrets as a way of protecting a formulation recipe in the past, they could now find themselves at risk of significant commercial harm if the recipe is disclosed due to a loss of trade secrets. However, demonstrating significant harm will be difficult for older active substances that are either generic or commodity products. New active substances and formulations will be protected by patents and that is probably the route of protection in future.
Do you think because of these changes to the General Food Law Regulation, we will see a change in how companies view trade secrets?
MC: Yes. I believe that companies will begin to view trade secrets as less than secure resulting in a greater move to patents to protect formulations and subsequently businesses from commercial harm. Alternatively, if the EU decides to make current trade secrets open, this could impact global trade. We may see global companies having reservations about registering products in the EU because these particular intellectual property provisions are at variance with most other world areas.
What do companies need to know about GLP and academic studies?
MC: GLP (Good Laboratory Practice) is mandatory under the new GFL regulations for industry studies. GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies to support research or marketing permits for products regulated by government agencies. Academic studies can be used in the regulatory process even though they will almost certainly not be to the GLP standard.
As industry views it, most companies would prepare dossiers with GLP studies so in this case, it is unlikely further action is needed. However, there are certain products where dossiers have obtained registration using mostly academic studies, which technically have no value from a regulatory point of view. In these cases, studies may require repeating to GLP standards in order to ensure compliance with the amended General Food Law.
What is Brexit’s impact on the General Food Law for UK companies?
MC: Whilst the UK is scheduled to leave the EU on 31 January 2020, the UK will still be subject to EU law up until the end of 2020. The current UK government’s position appears to be that after 31 December 2020, when EU law lapses, the UK will have a loose regulatory relationship with the EU; therefore the GFL may not be relevant to the UK when it comes into effect on 27 March 2021. This position may change during the course of 2020. Companies wanting to market their products in the UK will need to comply with future UK regulation. UK companies wanting to continue to market their products in the EU from 2021 onwards will need to ensure compliance with the amended General Food Law.
If you’re keen to find out what the GFL means for your company and how you can ensure it is GFL ready, sign up to our General Food Law Seminar on 18 February 2020. Save £100 if you register before 17 January 2020.
We also provide the GFL Diagnostic – an in-depth analysis of your business to ensure it is GFL ready and compliant; and GFL Tailored Training – bespoke training, drilling down to the specifics of your company. Find out more here.