The future of chemically defined & botanical flavouring in Europe

The regulatory framework in the feed industry is changing worldwide, particularly in Europe. In 2003, regulatory changes required that all feed additives must be evaluated by the European Food Safety Authority (EFSA), and obtain authorization to remain on the market. Under the patronage of the EU Association of Specialty Feed Ingredients and their Mixtures (FEFANA), several consortia were created, and categorized according to specific feed additive categories, for example, the Feed Flavouring Authorisation Consortium (FFAC) for flavours, and the Trace Elements Authorisation Consortium (TREAC) for trace elements. Pancosma & Associates is an active member of FFAC, tasked with negotiating the future of chemically defined and botanical flavours in Europe. 

Sebastien Oguey, Head of the Safety, Quality & Regulatory Department at Pancosma & Associates, has been involved in the FFAC consortium for years as a representative of the company. “The reauthorization process is still on-going and is very challenging for flavouring substances, especially with important changes in feed legislation taking place every year, for example, regulation 767/2009 on the marketing of feed. They impact the conditions under which feed products can be placed on the market,” explains Sebastien Oguey. “Therefore, the major challenges facing the feed industry are multifaceted: to keep existing authorized additives and products on the market, follow-up and anticipate the constant regulatory changes, and prepare authorization dossiers for innovative additives.” 

The feed additives industry, under the patronage of FEFANA, has created several consortia categorized according to specific feed additive categories, for example, FFAC for flavours and TREAC for trace elements. Sebastien Oguey elaborates further on the process, “The objectives of the consortia involved preparing and submitting reauthorization dossiers, which was successfully completed before the November 2010 deadline. Following this, EFSA began the evaluation process, and at the end of this procedure, EFSA will publish its opinion. The European Commission will then prepare a draft regulation, which will be submitted for approval or amendment to representatives of EU member states (SCoPAFF), following which a new regulation will be enacted.” 

Several challenges still remain, which vary depending upon the consortium. For some consortia, all of the additives concerned have already been evaluated and reauthorized, or are at the very end of the process. However, the situation is very different for other consortia, particularly for FFAC.  “A couple of additives have already been reauthorized (e.g. NHDC) or are just about to be reauthorized. However, for plant extracts the evaluation process has not even started yet. Moreover EFSA has stated that the data supplied for several substances is insufficient, and thus the industry needs to generate and submit large amounts of new data. This process is costly and time-consuming, leading many companies to withdraw from the consortium, which topped 40 members in 2010 and now in 2016, only 22 remain. For this reason, several flavouring molecules and botanical extracts will no longer be authorized in the future.”

More than 850 flavours are currently being evaluated, resulting in the submission of 58 dossiers: 36 dossiers for chemically defined flavourings (representing 591 molecules), 20 dossiers for botanical flavourings (270 molecules), and 2 dossiers for sweeteners. Clément Soulet, Product Manager – Palatants at Pancosma & Associates, manages the company’s leading range of sweeteners and flavours, which are highly affected by these regulatory changes. “We have dedicated an enormous amount of resources and a lot of time towards this project, to ensure that all of the flavouring molecules used by Pancosma are included in the reauthorization process being conducted by FFAC,” explains Clément Soulet.

The re-evaluation of flavouring substances extends to botanical flavours, and is of particular concern for Jennifer Maurin, Product Manager for Pancosma’s Plant Extracts range. “In 2014, a total of 268 botanical preparations were selected for re-evaluation by FFAC. This number will soon drop to around 200 due to the departure of some members from the FFAC consortium. The selection of botanical preparations determined to be important for the industry started in 2005, prior to the initiation of the evaluation phase, in which each member was allowed to identify botanical preparations of interest for them. During this period, Pancosma identified several botanical preparations that we use in our products, such as capsicum oleoresin. This phase was highly strategic as it will determine which molecules can stay on the market, and which molecules will potentially be approved for the development of innovative products in the future.”

The information required for these dossiers include product identification data and experimental evidence that the molecules under consideration are safe for animals, for workers who handle them, for consumers, and for the environment. The result is that the FFAC consortium has had to deliver large volumes of data relating to methods of analysis, manufacturing process, physical properties, animal tolerance, safety, metabolism, and studies regarding residues, as well as environmental risk assessments. Whereas some data already exist, further data had to be generated by conducting key trials. Furthermore, when it comes to products based on plant extracts, the complex nature of botanical preparations means that the requirements are even more demanding, necessitating further experiments to obtain additional knowledge on botanicals. The massive costs required for carrying out these additional tests and trials were shared by FFAC members.

“In this respect, Pancosma has consistently dedicated a significant portion of its yearly budget and resources to obtain the required data for the re-evaluation processes. Regarding our products in Europe, I am not worried at all for several reasons. First, as a leading feed flavouring manufacturer, Pancosma is member of FFAC as an important contributor to the consortium, as well as being part of the steering committee. Consequently, we have up to date information on the progress regarding the reauthorization of flavouring substances, and we are also able to decide on the products to be defended and on their conditions of use. It gives us visibility, which a non-FFAC member would not have. I am, therefore, confident that Pancosma will not be significantly impacted by any flavouring molecules which may be withdrawn from the market,” states Clément Soulet. “Secondly, in the event that a few flavours might not be included in the list of molecules for reauthorization, Pancosma’s expert team of flavourists is absolutely able to reformulate flavours, to substitute or reduce part of a flavouring product for a given formula. Flavour reformulation is highly complex and requires state-of-the-art expertise and knowledge, all of which are part of Pancosma’s DNA. Moreover, I believe that this re-evaluation process will be a great advantage to our customers, since it will reaffirm that the ingredients we select for our products following careful sourcing, rigorous testing and analysis, are 100% safe for animals, consumers, the environment, and also the workers who handle these substances. Finally, Pancosma has always been transparent and proactive regarding legislation concerns. We attach great importance to the safety of our products and view this project as an opportunity rather than a problem.”

Considering the future of plant extracts used in feed, Jennifer Maurin concludes, “We have ensured that our product portfolio will remain unaffected by identifying all the botanical preparations of interest for Pancosma. If their re-authorization succeeds, all of the ingredients we use will continue to remain available in Europe. This is vital for our customers, the actual users of our products, who frequently ask us questions related to this issue. It is important for customers to know that the products they use in their daily feed formulation targeted for the European market, are being defended by the manufacturers who produce them. At Pancosma we are committed to our customers, and we have always been transparent regarding the components of our products, and moreover, we know exactly how our products work and their effects. This process will also make it increasingly difficult for those providers, who up until now have managed to sell products with black boxes – essentially botanical preparations with unknown and undeclared active ingredients, and properties.”

The European feed industry is currently at a major crossroads, and the work being done by the FFAC consortium and the resulting outcome of EFSA’s opinion, will determine its future by defining the molecules of tomorrow. Regulatory changes enacted in Europe have the potential to affect markets beyond its borders. As the world keeps a close watch and waits for the outcome of what is happening in the European feed industry, the potential consequences in other major global markets such as the US, Canada, and China remain to be seen.