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Probiotic claims on the horizon – so long as new EFSA dossiers keep it simple, say regulatory experts
Companies keen to do the so-far impossible – gain an EFSA approved health claim – should hold oﬀ on applications for now, and ensure new dossiers are kept simple in the future, regulatory experts told delegates at the recent IPA World Congress + Probiota 2018.
Consumer acceptance: Novel probiotics are beneficial, but the food industry is ‘its own worst enemy’ on GM technologies
Eﬀorts to mine for hugely beneﬁcial new strains of probiotics are gaining momentum across the globe, but the food industry is its own worst enemy when it comes to aiding consumer acceptance of new technologies, according to experts at the recent IPA World Congress + Probiota 2018.
The number of nutrition industry professionals who find the EU regulatory framework unhelpful has risen sharply over the past year, research shows. Experts believe dissatisfaction has risen because of the EU’s tough stance on health claims and the continuing regulatory deadlock on botanicals.
The new regulations on novel foods, defined as anything without a significant history of consumption in the European Union before May 15, 1997, came into force on January 1, 2018, signalling the start of a new system operated by the European Commission.
Just before the end of 2017, the European Commission published the long-awaited Union list of novel foods allowing food business operators (FBOs) to sell any of the 125 approved novel plants, extracts, microorganisms, vitamins, minerals, etc. in the European Union without undergoing a pre-registration assessment.
Concerns over the safety of E. faecium for use as a probiotic food supplement have been raised due to the propensity of this microbe to develop and acquire AMR, especially to vancomycin and ampicillin. The US and Taiwan FDA (Food and Drug Administration) believe that, in general, AMR can be transferred from “wild-type” bacteria residing in the gut to probiotics in transit through the gut. Consequently, health authorities all over the world are closely monitoring the development of AMR, including the use of E. faecium as a probiotic in food and feed.
While regulators strive to ensure a safe food chain from farm to fork, the regulatory systems relating to probiotics vary greatly around the world. So, what are the regulatory hurdles related to novel food probiotics and how should we approach them from an EU regulatory perspective?
Efficacy is the main talking point as the EU Commission (EC) revises the EU feed additives regulation. That legislation (Regulation (EC) No 1831/2003) has not undergone an evaluation since its entry into force in October 2003. Elinor McCartney, president of food chain consultancy group, Pen & Tec, weighed in some of the outstanding issues.
The new regulations on novel foods come into force on 1 January 2018. Many people working in the nutrition industry feel positive about the EU’s new process for the approval of novel foods, new research by the organisers of Vitafoods Europe shows. However, experts are warning that there could be adverse implications for some companies’ intellectual property portfolios.
On 17 October 2017, the EFSA FEEDAP Panel published three new guidance documents to help applicants with the preparation of feed additive submissions. These guidance documents were adopted during the last FEEDAP plenary meeting in September 2017 and will enter into force on 1 May 2018.
IPA World Congress + Probiota 2018 is coming to Barcelona, 7-9 February and will bring together leading experts to present the latest scientific, technical and market insights. From performance and sport to regulation and marketing, Probiota will bring business and academia from across the globe to discuss the latest innovations and growth in today’s market.
EFSA launch public consultation on the draft guidance for the assessment of the efficacy of feed additives – 28th January deadline
EFSA has recently published the Draft Guidance for the Assessment of Efficacy of Feed Additives, which will be available for public consultation until the 28 January 2018.
EFSA FEEDAP Panel published three new guidance documents to help applicants with the preparation of feed additive submissions and is also working on updating a fourth guidance (Guidance on the characterisation of microorganisms used as feed additives or as production organisms), expected to be adopted during the next FEEDAP meeting, scheduled in November 2017.
Dr Hannah Lester was invited to moderate a Panel Discussion on “Sharing Experiences of Regulatory Processes and Policies” at the Feed Additives 2017 conference, with a focus on how applicants can work smarter and be more efficient during EU registration processes.
Two-day annual conference: A regulatory update on animal feed and feed additives in the EU, USA and China
Pen & Tec have joined forces with Management Forum to hold a conference on the legislation governing feed and feed additives in the EU, USA and China, with guest speakers including representatives of the EC, EFSA and the Animal Feed Unit of Spain’s Ministry of Agriculture.
New regulations for the approval of novel food come into effect in the EU on 1st January, 2018. What impact will this have on the industry and how will it affect new product development? Ing. Liza van den Eede from Pen & Tec Consulting will be at the Fi Europe Conference to clarify the new procedures and answer your questions about the new approval process.
EFSA drives initiatives on stakeholder engagement and insights on Brexit – Dr Elinor McCartney’s interview for Fi Europe 2017
Navigating the choppy waters of F&B regulations can be challenging, especially with pending changes in EU regulations and Brexit looming large. Regulatory experts Dr. Elinor McCartney will be at the Fi Europe Conference to share her expertise and answer your questions.
New European rules intended to speed up and simplify introduction of novel foods continue to raise concern among companies about confidentiality and transitional measures, including that all authorisations will be generic rather than specific to the applicant. However, applications that are still ongoing by the beginning of 2018 will benefit from the five-year protection period as they can inform the authorities which studies are proprietary, if any.
We are pleased to announce that Dr Elinor McCartney and Ing. Liza Van den Eede will be speaking at Food Ingredients Europe 2017 on 28-30 November in Frankfurt, Germany. The presentations will cover the new novel food regulation and EFSA initiatives for improved stakeholder engagement.
We have become an official sponsor of Feed Additives 2017, which will take place on 27-29 September in the Frankfurt Marriott Hotel, Germany. We will sponsor drinks reception and will be happy to welcome you!
AAFCO hold an annual meeting to enable control officials and individuals from the animal food industry to better understand and interpret the regulations. It is also a good opportunity to learn about recent changes and updates in the registration process and to network with FDA officials.
Future global regulation of probiotics for humans and animals – preview of Dr Elinor McCartney’s presentation at IPC2017
If you are thinking of bringing a probiotic to market, you will need to have the right knowledge and understanding of how they are regulated before you take the plunge. Dr Elinor McCartney’s presentation at the International Scientific Conference on Probiotics and Prebiotics will give an insight into the latest regulatory developments and challenges facing probiotics, with special focus on EU legislation.
The European Commission announced in its Better Regulation Communication of 19 May 2015 that it plans to carry out a Regulatory Fitness and Performance evaluation of the EU legislation on nutrition and health claims.
EFSA Public Consultation on the FEEDAP Panel’s guidance on the assessment of the safety of feed additives for the target species
EFSA’s Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has launched an open consultation on a draft guidance on the assessment of the safety of feed additives for the target species. This document will update the current guidance to applicants for the preparation and the presentation of an application for authorisation of a feed additive.
Pen & Tec will be attending ESPN 2017, which will be held in Salou, Tarragona, Spain, during May 8-11, 2017. Will you be attending this event? Why don’t you contact us to arrange a meeting?
Pen & Tec has been accepted as an associate member of the British Association of Feed Supplement and Additive Manufacturers (BAFSAM). As members of BAFSAM, Pen & Tec will be able to contribute towards negotiations on what the feed industry may look like post-Brexit, and we will receive regular updates on any developments.
Will you be attending this event in Geneva, Switzerland? Why don’t you contact us to arrange a meeting? We are looking forward to meeting some of our existing clients and keeping up to date with current trends and latest developments for food ingredients and dietary supplements.
The marketing of botanicals in the EU remains complex, and harmonisation between Member States has proven difficult and causes confusion. Find out how to improve the wording of claims and increase your chances of gaining a successful approval.
Due to technical and scientific changes that mainly impact the workload of the panels, EFSA decided to shift tasks & assignments between the food panels (CEF, ANS and NDA). Pen & Tec will be attending EFSA’s Info Session on Novel Foods in March. The objective is to discuss the requirements of the new novel food guidance.
Pen & Tec will deliver a comprehensive introduction to the entire regulatory dossier submission process for approval of a feed additive in the EU. This is an excellent networking opportunity as delegates will also be able to work on case studies during the interactive workshop sessions.
EFSA held a meeting regarding the proposed changes to the FEEDAP technical guidance documents. What are the potential benefits to industry? How will this help applicants? Find out more by reading recently published Pen&Tec article.
Pen & Tec Consulting will be attending the next IPPE Expo in Atlanta from 31st January to 2nd February 2017. Feel free to contact us and schedule a meeting to find out how Pen & Tec can help bring your product range to Europe and accelerate time to market.
Join us at “A regulatory update on animal feed and feed additives in the EU, USA and China” 8-9 December 2016, London
Management Forum, supported by Pen & Tec Consulting, are organising their annual update legislation governing feeds and feed additives in the EU, USA and China.
The result of the recent UK referendum on the decision to leave the European Union has sent shockwaves across many industries globally. But what does it mean for the food and animal health industry?
Update of regulatory guidance on feed additives: EFSA asks for feedback and views from industrial stakeholders
The EFSA FEEDAP Panel has recently started to revise guidance documents for the risk assessment of feed additives. In order to engage with applicants and stakeholders, EFSA has organised a two-day technical meeting, which will take place on 14 and 15 July 2016 in Brussels to discuss scientific issues relating to the preparation, scientific evaluation and risk assessment of applications for market authorisation of feed additives.
Pen & Tec Consulting held a 2-day practical course with interactive workshops to provide training on the entire procedure for obtaining a marketing authorisation for a feed additive in the European Union, under Regulation (EC) No 1831/2003 and Regulation (EC) No 429/2008. The course was designed to help applicants avoid unnecessary delays in the registration process and speed up time to market.
Update on the Regulatory Landscape of Probiotics – Preview of Dr Elinor McCartney’s Presentation at IPC2016
If you wish to be informed on details of the probiotic regulatory landscape and learn about the golden rules of registration dossier preparation attend IPC this year on 21 – 23 June in Hungary.
If you wish to be informed on details of the probiotic regulatory landscape and learn about the golden rules of registration dossier preparation attend IPC this year on the 21st – 23ed of June in Hungary.
The new novel food regulation introduces a centralised authorisation procedure (Regulation 2015/2283). Even though the regulation will only be applicable from the 1st of January 2018, food business operators need to be aware of some crucial changes which the regulation brings.
Pen & Tec, with the collaboration of Management Forum, will hold a 2-day introductory course on the registration of feed additives in the EU in London, 19-20 May 2016. This course is suitable for regulatory affairs managers, R&D scientists and marketing specialists who wish to learn about the regulatory requirements to legally sell a feed additive in the EU.
The latest achievements, new developments and innovative ideas for the use of beneficial microbes were discussed at the 4th “Beneficial Microbes” symposium in Berlin this January, held by one of Pen & Tec’s clients: Organobalance. This year’s event reviewed novel uses in health, chemistry and cosmetics applications.
A one-day interactive workshop took place in central Brussels on Friday 5 February 2016. Over 80 participants from the European Food Industry, Legal affairs and Clinical research companies joined to learn how to comply with the EU Food Regulatory framework.
Based on recent experience of food enzyme dossiers received, EFSA is drafting a statement on exposure assessment for food enzymes, due to be published between June and September 2016. The objective of the technical meeting was to share and explain EFSA´s updated approach and to increase collaboration with applicants with the aim of achieving a more transparent evaluation process.
Management Forum, together with the help of a panel of expert speakers and Dr Elinor McCartney as Chairperson, convened a 2-day conference and interactive workshops to provide a “Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China”. This year’s conference attracted delegates from all over the world, wishing to learn about the latest changes in animal feed and feed additive legislation in Europe, USA and China, with a key focus on European requirements.