In 2014, new rules came into force on nature-based innovation, including in the European Union. These rules on access and benefit sharing (ABS), as the topic is known, are impacting companies involved in R&D on natural ingredients. This includes companies in the food sector, including those working with nutraceuticals. María Julia Oliva, an international expert on ABS working at the Union for Ethical BioTrade (UEBT), explained more.
How are ABS rules relevant for the food ingredients, such as nutraceuticals?
ABS rules may be relevant for a significant part of R&D in the food and beverage industry. National laws and regulations on ABS may differ. However, the trigger for ABS, or access to genetic resources and fair and equitable benefit sharing, is generally R&D on the genetic or biochemical composition of plants, animals or microorganisms. For example, activities such as exploring seed oils for new natural sources of vitamin, developing algae-based pigment supplements for use in nutraceuticals, and using technology to enable new applications of plant extracts in functional beverages may be impacted by legal requirements on ABS. Other types of research, such as chemical and microbial testing for quality and toxicity, are not likely to be affected.
And in the European Union, for instance, which activities trigger ABS requirements?
The EU regulation on ABS, which came into force in 2014, focuses on R&D on the genetic or biochemical composition of living organisms. Official guidance is currently being prepared that will look at how biodiversity is used in R&D in various sectors and clarify what can be considered within and outside the scope of the EU regulation on ABS. Until then, there are no definitive parameters, although the EU regulation is already in force.
Nevertheless, it is important to consider that the EU regulation on ABS seeks to ensure that genetic resources used in R&D are accessed in compliance with ABS requirements in countries that have committed to the UN Nagoya Protocol on ABS. That is, the need for companies to adopt due diligence – the main obligation under the EU regulation – also depends on the country where the genetic resources where accessed, as well as other factors. UEBT has illustrated the applicability of the EU regulation on ABS in an infographic on the EU regulation.
￼The main obligation in the EU regulation on ABS is due diligence; what does that mean and how is such due diligence proven?
Due diligence requires measures to gather, manage and transmit information relevant to ABS compliance; it implies being able to trace the source and date of access to the genetic resources, as well as any relevant permits. Two “checkpoints” are established to ensure that companies and other organisations conducting R&D comply with due diligence. These are: receiving public or private research funding in the form of a grant; and reaching the final stages of product development. The latter includes placing the product on the market, or transferring research results. More information is available in the implementing rules for the EU regulation or, more simply, in the UEBT infographic.
What type of R&D triggers ABS requirements in other countries?
It differs from country to country. National laws and regulations have quite a bit of flexibility in establishing the scope of ABS requirements. Right now, for example, using natural ingredients for nutraceuticals is covered by rules on ABS in Brazil and South Africa, but expressly excluded in Peru. This can be difficult for companies. Also, most countries are still developing or revising their rules and governance structures on ABS. This means that – for now – information on the scope of requirements or on specific procedures can be limited or confusing.
How can companies obtain relevant information?
There is a UN information exchange platform (the ABS Clearing House of ABS). This is a helpful tool, but depends on countries notifying and updating information on their ABS requirements. Additional guidance – also focusing on actual practices, costs and timelines – is therefore needed.
UEBT support companies through guidance on rules and practices on ABS in key countries. Companies working with UEBT have access to a list describing ABS laws and regulations in countries around the world. And UEBT has prepared a number of ABS fact sheets, which describe ABS rules and practices in various countries, and other information documents that are available on the UEBT resources page.
How will the UEBT conference on 26 May address these issues?
During the UEBT conference companies such as Nestlé and L’Oréal will share their approaches to due diligence in R&D and other activities. Other sessions will feature detailed, step-by-step accounts of negotiations for ABS permits and contracts, including in Brazil and Morocco.
© FoodBev Media Ltd 2020