The Dutch National Probiotic Guide: an innovative alternative for health claims on beneficial bacteriaPosted: August 24, 2018 | |
Probiotics are known as “beneficial bacteria” that can be found in, amongst others, dairy products and food supplements. They are defined by the joint FAO/WHO expert consultation on probiotics as “live microorganisms that, when administrated in adequate amounts, confer a health benefit on the host”. Since the reference to probiotics implies a health benefit, it comes as no surprise that the statement “contains probiotics” in a commercial communication about a food product constitutes a health claim under the Claims Regulation. Moreover, “contains probiotics”, or “prebiotics”, is explicitly taken as an example of a health claim in the guidance on the implementation of Regulation 1924/2006 of the European Commission’s Standing Committee on the Food Chain and Animal Health. At this moment, no health claims for probiotics have been approved by the European Commission. The Dutch Research institute TNO and the world’s first microbe museum Micropia, located in Amsterdam, are nevertheless convinced of the health benefits of probiotics, in particular to protect against antibiotic-associated diarrhea (AAD). At the beginning of this month, they launched a so-called National Guide on clinically proven probiotics for use during antibiotic treatment in the scientific journal BMC Gastroenterology
The National Guide is presented as a tool for healthcare professionals, patients and other consumers to recommend or use the probiotic products listed as scientifically proven to prevent diarrhea caused by the use of antibiotics. While antibiotics fight bacterial pathogens, they also have a disruptive effect on the body’s own gut bacteria. One in four adults experiences diarrhea caused by ADD. The National Guide promotes probiotics for their function of protecting the gut flora from the disruptive effects of antibiotic treatment, fostering recovery and reducing the risk of recurring infections.
The research behind the Guide involves a literature study of clinical studies that are all based on randomized, double-blind and placebo-controlled trials. Moreover, all of the trials clearly define AAD and have a probiotic administration regime for a period no shorter than the antibiotic therapy. 32 of the 128 initially identified clinical studies were selected in line with the aforementioned criteria. After the selection and review process, available probiotic products on the Dutch market were listed to be subsequently matched with the formulations as proven effective in the selected clinical studies. Only eight probiotic dairy products and food supplements marketed in the Netherlands specified on their label the respective probiotic strain(s) and number of colony-forming units (CFUs) and could therefore be used in the research. The listed probiotic products were awarded with one (lowest) to three (highest) stars for their proven effect as demonstrated in at least one to three clinical studies. The strain Lactobacillus rhamnosus GG with a minimal daily dose of 2 × 109 CFU was found in at least three clinical studies and therefore awarded with a three-star recommendation. This strain was found in 2 products, both of which are food supplements. Several multi-strain formulations resulted in a one-star recommendation; 5 food supplements and 1 dairy product matched such a formulation. The multi-strain formulation Lactobacillus rhamnosus GG, Lactobacillus acidophilus LA-5 and Bifidobacterium lactis BB-12 was present in two clinical studies and therefore assigned with a two-star recommendation. However, none of the listed probiotic products found on the Dutch market contained this formulation.
Plea for the labeling of probiotics
The research is not exhaustive as probiotic products other than the eight that were included in the study might also be effective. However, since this was not communicated on the label, they could not be included in the research. To overcome this gap, TNO and Micropia as the initiators of the National Guide call for the labeling of the probiotic strains and number of CFUs on all probiotic products EU-wide. This could also expand the potential of the Guide. At this moment, strain and CFU labeling of probiotic products is not legally mandatory under the Food Information for Consumer Regulation. The initiators also developed a special probiotic label to address this claimed deficiency. The label is based on the probiotic label used in the US as created by the International Scientific Association for Probiotics and Prebiotics (ISAPP). The labels are in line with the information that should be demonstrated on probiotic labels according to the FAO/WHO 2002 Working Group on Guidelines for the Evaluation of Probiotics in Food.
National Guide to circumvent limitations under the Claims Regulation?
The Claims Regulation applies to health (and nutrition) claims made in commercial communications of foods to end consumers. This may be in the labeling, presentation or advertising of the food. Besides information on or about the product itself, also general advertising and promotional campaigns such as those supported in whole or in part by public authorities fall within the scope of the Regulation. Moreover, since the Innova Vital case, we know that (science-based) communications made to healthcare professionals may also be regulated by the Claims regulation. The rationale thereof is that the healthcare professional can promote or recommend the food product at issue by passing the information on to the patient as end consumer. Only non-commercial communications, such as publications that are shared in a purely scientific context, are excluded from the Regulation.
It must be noted that the National Guide is, unlike health claims, not a commercial communication originating from food business operators. This does, however, not necessarily mean that food business operators are free to use the science-based Guide in their communication with (potential) consumers or even with healthcare professionals without any reservation. The Guide, which not only lists the probiotic formulations that are beneficial for the human gut flora, but even the names of products that contain those formulations, could turn commercial when referred to by a food business. Moreover, when shared in such a context, the claims made in the National Guide may even enter the medical domain due to the preventive function assigned to foods containing probiotics.
The history of probiotic health claim applications has shown that EFSA is not easily convinced of the evidence that is correspondingly provided. The National Guide is, however, not subject to approval from the European Commission, backed by a positive opinion from EFSA. The Guide’s publication in the peer-reviewed journal BMC Gastroenterology nevertheless contributes to the verification of its scientific substantiation. The Guide therefore appears as an innovative, science-based alternative for probiotic health claims. At the same time, food business operators should be careful in referring to the National Guide to not act beyond the borders of the Claims Regulation and to stay away from medical claims. As a very minimum however, it seems to be valuable work to be adopted by branch organizations or research exchange platforms, such as the International Probiotics Association.
The organic sector has developed from a niche market to one of the most dynamic sectors of EU agriculture. To recall some numbers provided by the European Commission, the amount of land used for organic farming grows at around 400,000 hectares a year. The organic market in the EU is worth around €27 billion, some 125% more than ten years ago. The EU encourages more farmers into the organic sector and aims to increase consumers’ trust in certified organic products to further boost those numbers. For some background on the regulatory framework, we refer to our earlier blogpost on the Organics Regulation. As already announced in that post, the current Council Regulation (EC) No 834/2007 needs an update as it is based on practices of over 20 years ago. The first proposal for a new EU Regulation on organic production dates back to 2014. Last month, the European Parliament Committee on Agriculture and Rural Development gave green light to the new Organic Regulation. This new regulation aims to guarantee organic production throughout the supply chain by phasing out the many exemptions that are allowed under the current Regulation, such as the use of non-organic seeds as further covered below. In other words, the new regulation shifts from an à la carte system of exceptions to a set menu of harmonized rules. This contribution sets out the most important changes by answering relevant questions in the light of the new Organic Regulation.
Which products are covered under the new Organic Regulation?
Similar to the current Organic Regulation, the new Organic Regulation applies to live and unprocessed agricultural products, including seeds and other plant reproductive material and processed agricultural products used as food and feed. Processed products can be labelled as organic only if at least 95% by weight of their ingredients of agricultural origin are organic. Unlike the current Organic Regulation, the new Organic Regulation also covers certain other products closely linked to agriculture. Those products are listed in Annex I and include, among others, salt, essential oils, cork, cotton, and wool. Other products may be added in future.
To what extent can non-organic seeds still be used?
Derogations that allow non-organic seeds to be used in organic production will expire in 2035. A couple of measures will be taken to increase the organic seed supply and to help it meet high demands before that time. First of all, Member States shall establish a database of organic plant reproductive material as well as national systems that connect organic farmers with suppliers of organic reproductive material. Secondly, the use non-organic seeds may temporarily remain allowed if the collected data demonstrates insufficient quality and quantity of the organic reproductive material. Also, to meet the demands of organic seeds, organic heterogeneous material is explicitly allowed for in Article 13 of the new Organic Regulation and production criteria for organic varieties are adapted taking into account the specific needs and constraints of organic production. The derogations may be phased out earlier than 2035 or extended based on a report due in 2025, which will examine the situation of plant reproductive material on the market.
Are mixed farms still allowed under the new Organic Regulation?
While the initial proposal of the Commission proposed to ban the production of organic products and conventional products at the same farm, mixed farms continue to exist under the new Organic Regulation. Mixed farms are allowed provided that the two production activities are effectively separated into clearly distinct production units. This means, among others, that inputs for production as well as the final products must be separated to avoid contamination and potential fraud. Also, the two production activities should involve different livestock species and plant varieties.
What measures must be taken to avoid contamination from non-authorized substances?
EU thresholds for conventional products automatically apply to organic ones too. Stricter thresholds for non-authorized substances in organic products are not introduced. This would include high costs, especially for small farmers, to control for example contamination from neighbouring conventional farming. Instead, food business operators are obliged to take precautionary measures to avoid contamination. The responsibility and accountability of organic producers will thus be emphasized. Final products are not allowed to bear the organic label when the contamination was deliberate or caused by irresponsible food business operators that failed to take precautionary measures. Meanwhile, Member States remain at liberty to set specified thresholds for non-authorized substances in organic products, provided that these national rules will not affect the trade of organic products that are legally placed on the market in other Member States. Based on a report due by the end of 2024, anti-contamination rules and national thresholds may be further harmonized in future.
How does the new Organic Regulation ensure the high quality of organic products?
Rather than moving all the control provisions into the regulation on official controls for food and feed, as initially proposed by the Commission, specific rules will apply to the control of organic farming. Organic production refers to the use of production methods that contribute to the protection of the environment, animal welfare, and rural development. Risk-based checks will therefore not be limited to final products but take place along the supply chain to guarantee that organic products are truly organic. Physical on-site checks will take place at least annually; the on-site check may be reduced to once every two years if the food business operator has been fully compliant for three years. In the Netherlands, those inspections are carried out by SKAL as the the designated Control Authority responsible for the inspection and certification of organic companies.
What does the new Organic Regulation mean for products imported into the EU?
Under the current Organic Regulation, organic products produced in third countries are allowed on the EU market when the organic standards of the exporting country are similar to EU rules. This means that organic products are in fact regulated by over 60 different standards. Under the new Organic Regulation, all imported products will have to comply with EU standards. Taking into account the date of application of the new Organic Regulation as well as the transitional period granted for imported products, this rule will only apply as from 2026. Moreover, certain exceptions are introduced to avoid disruptions of supply on the EU market. First of all, the Commission is empowered to grant specific authorization for the use of products and substances in organic production in third countries with specific climatic and local conditions, which therefore cannot comply with the new requirements. This exception also applies to organic production in the EU’s outermost regions, such as the Nordics. Secondly, equivalent production methods in third countries could be recognised under trade agreements.
The new Organic Regulation promises to further boost EU organic production. Measures to increase the supply of organic seeds and animals, allowing mixed farming, and no harmonized thresholds for non-authorized substances aim to attract more farmers into organic production. Meanwhile, measures are taken to increase consumers’ trust in organic products, such as through risk-based checks along the supply chain and the switch from the principle of equivalence to an EU single set of rules for imported products. We expect this to be a major improvement for the algae sector, that suffers unfair competition from Asian countries, where organic standards are not necessarily the same as in the EU.
It takes some more years to see to what extent the Regulation will live up to its promises. While the Regulation itself only becomes applicable from 2021, many rules are subject to further implementation depending on the development of the sector. This illustrates the dynamic character of the organic sector, which creates many opportunities for food business operators active in this field.
Last month, the European alcoholic beverages sectors handed over to the European Commission a self-regulatory proposal on the provision of nutrition information and ingredients listing. Article 16(4) of the Food Information for Consumers (FIC) Regulation exempts alcoholic beverages containing more than 1.2% by volume of alcohol from the mandatory list of information and nutrition declaration. Nevertheless, it also attributes the Commission with the task to investigate whether and to what extent alcoholic beverages should nevertheless be covered. Last year, the Commission established in its report, amongst others, that the provision of nutrition information and ingredients listing could help consumers to make informed choices about what and how much to drink. The alcoholic beverages sectors have been asked to present a self-regulatory proposal to respond to consumers’ expectations as they have done last month.
In their proposal, the alcoholic beverages sectors elaborate on the details on the communication of the nutrition information, the list of ingredients, and the means of delivering this information to consumers. The sectors aim to provide consumers with meaningful information while preventing to create new burdens for SMEs. In this blog we give a short overview of the proposal, which should be read together with the sector-specific annexes for beer, cider, spirits and wine that allow for sector-specific implementation of the proposal.
According to the FIC Regulation, nutrition information must be given per value of 100 ml of the product and may additionally be provided per portion size. Nutrition information involves the energy value and the amounts of fat, saturates, carbohydrate, sugars, protein and salt, but may also be limited to the energy value only. The spirit sector emphasizes in its annex that it is most meaningful for consumers to provide the information in portion size and adds that the energy value per 100 ml might be misleading, as spirits are never served in this quantity. To provide accurate nutrition information, food business operators may carry out analysis on their products or they can use generally established and accepted data. The alcohol beverages sectors stress the importance of the latter option due to the changing nature of certain alcoholic beverages as they age (wine) and depending on the harvest (e.g. cider). Moreover, said data will also reduce the burden for analysis by SMEs. The wine and spirits sector have already provided such a toolkit in their annexes to the proposal, using average values of typical and characteristic wines. For instance, 100 ml of brut, sparkling wine provides 70 kcal.
As for the list of ingredients, Article 20 of the FIC Regulation excludes food additives or food enzymes used as processing aids from this list. The wine sector specifies that this means that only additives permitted for wine-making not considered processing aids during the wine-making process shall be included in the list of ingredients. Moreover, the sector notes that natural substances used to adjust the grape composition (acidity and natural sugar content) do not have to be listed; those substances only aim to restore the basic balance and composition where harvest conditions are not optimal. The wine annex is already rather concrete in the sense that it shows in its appendix I a list of oenological compounds that, when used, will have to be included in the list of ingredients.
Lastly, the proposal embraces new information and communication technologies to inform the consumer on the nutrition declaration and list of ingredients. This is in line with recital 51 of the FIC Regulation, according to which food information rules should be able to adapt to, amongst others, a rapidly changing technological environment. Next to traditional on label information, off-label information that can be accessed via a web-link, QR code, bar code or other direct means of using smart technologies are suggested in the proposal. The wine sector refers in its annex for example to the website of ‘Wine in Moderation’ as a tool to comply with labeling requirements by off-label means. The alcoholic beverages sectors propose to leave it up to the food business operators how to display the information.
The alcoholic beverages sectors commit themselves to report on implementation in March 2021. The proposal will now be assessed by the Commission. Green light will allow for high spirits to make information on alcoholic beverages crystal clear. However, all four sectors (beer, cider, spirits and wine) must be working hard on more concrete implementation guidelines that can be used by their member companies, who have to do the actual job. For the time being, the wine and spirits sector so far have elaborated the most concrete proposals. We will continue to monitor and report on further developments in this field.