12 BIOGAIA SUSTAINABILITY REPORT 2021 Materiality and risks Misleading or unsubstantiated claims in marketing are a threat to consumer confidence and the company’s credibility. One of BioGaia’s strengths is the large number of studies conducted using BioGaia’s probiotic strains and which are published in scientific journals. L. reuteri DSM 17938, is the world’s most scientifically studied probiotic bacterium that remains patented. Clear, transparent and easily accessible information about the research reduces any confidence and brand risks. How work is conducted BioGaia’s product development and marketing is based on robust clinical scientific documentation on safety and efficacy of the strain or strain combination used in a product. To ensure that the company’s products are of the highest quality and that they comply with international criteria for probiotics, BioGaia applies the International Scientific Association for Probiotics and Prebiotics (ISAPP) criteria for probiotic products. These govern, for example, how the probiotics should be labelled, see the table “Criteria for probiotics and BioGaia’s assessment of level of compliance” on page 13. BioGaia is continuing to invest in pre-clinical and clinical studies on existing and new strains, combinations of strains and end products. The studies vary in scope as does the extent of the company’s involvement – ranging from BioGaia assisting in the planning of the study to the company solely supplying products and its placebo to those responsible for the study. All studies carried out on BioGaia’s products follow the Good Clinical Practices (GCP) standard, as defined by the International Conference of Harmonisation (ICH). BioGaia only communicates product claims that are truthful, accurate, clearly distinguishable and balanced. The products may only be marketed using health claims that can be supported by results from clinical trials and otherwise comply with laws and regulations. This require- ment is included in the Code of Conduct signed by BioGaia’s distributors. The distributors are trained in the science behind BioGaia’s products and are provided with marketing material that is firmly based in research. If BioGaia becomes aware of any risks related to the use of its products, the company is committed to being transparent towards the market and consumers. Progress and priorities going forward In 2021, 22 new articles were published relating to BioGaia’s products and strains. BioGaia remains active in the International Probiotics Association (IPA), a non-profit organisation that aims to create a united voice for probiotics worldwide. Through IPA Europa, the European arm of IPA, BioGaia contributes to work to promote a favourable environment for probiotics in the short and long term. The aim of IPA is to: Establish probiotic standards and voluntary guidelines to define the conditions for probiotics use. Establish a harmonised legal status for probiotics in the EU. Play an active role in the European Food Safety Authority’s (EFSA) consultation process to ensure a suitable environment for the drafting of probiotics health claims. Engage in dialogue with all relevant stakeholders to raise awareness and knowledge about probiotics. During the year, BioGaia was active in regulatory and scientific discussions and contributed to the production of “Probiotic talks from IPA EU,” a campaign on healthy ageing and probiotics. 2021 was an exciting year, as Poland, the Netherlands and Denmark chose to allow the use of the word probiotics as a mandatory category name for food supplements. Read more about IPA on: www.internationalprobiotics.org Published articles on clinical studies (BSD 1) Product Strain or strain combination 2021 2020 2019 Protectis L. reuteri DSM 17938 165 153 1441) Prodentis L. reuteri DSM 17938 & L. reuteri ATCC PTA 5289 61 53 45 Gastrus L. reuteri DSM 17938 & L. reuteri ATCC PTA 6475 7 6 6 Osfortis L. reuteri ATCC PTA 6475 1 1 1 Total number of articles2) 236 214 198 1) Including articles with the mother strain L. reuteri ATCC 55730 2) Total number of published studies at year end on BioGaia’s probiotic strains, including articles (2) based on studies of products yet to be commercialised. Well-documented products & transparent product information (GRI 3-3) Healthy products CONTENTS
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