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href="https://ehpm.org/food-supplements/" class="fusion-bar-highlight"><span>WHAT THEY ARE</span></a></li><li id="menu-item-1369" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-1369 fusion-dropdown-submenu" ><a href="https://ehpm.org/food-supplements-tabs/" class="fusion-bar-highlight"><span>EUROPEAN REGULATORY FRAMEWORK</span></a></li><li id="menu-item-1370" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-1370 fusion-dropdown-submenu" ><a href="https://ehpm.org/food-supplements-tabs/#main-2" class="fusion-bar-highlight"><span>SUBSTANCES & INGREDIENTS</span></a></li><li id="menu-item-423" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-423 fusion-dropdown-submenu" ><a href="https://ehpm.org/ehpm-standards/" class="fusion-bar-highlight"><span>EHPM QUALITY STANDARDS</span></a></li></ul></li><li id="menu-item-435" class="general-regulatories menu-item menu-item-type-post_type menu-item-object-page current-menu-ancestor current-menu-parent current_page_parent current_page_ancestor menu-item-has-children menu-item-435 fusion-dropdown-menu" data-classes="general-regulatories" data-item-id="435"><a href="https://ehpm.org/regulatory-issues-2/" class="fusion-bar-highlight"><span class="menu-text">REGULATORY CHALLENGES</span> <span class="fusion-caret"><i class="fusion-dropdown-indicator"></i></span></a><ul class="sub-menu"><li id="menu-item-23" class="menu-item menu-item-type-custom menu-item-object-custom current-menu-item menu-item-23 fusion-dropdown-submenu" ><a href="https://ehpm.org/regulatory-issues/#main-1" class="fusion-bar-highlight"><span>MUTUAL RECOGNITION</span></a></li><li id="menu-item-171" class="menu-item menu-item-type-custom menu-item-object-custom current-menu-item menu-item-171 fusion-dropdown-submenu" ><a href="https://ehpm.org/regulatory-issues/#main-2" class="fusion-bar-highlight"><span>HEALTH CLAIMS</span></a></li><li id="menu-item-172" class="menu-item menu-item-type-custom menu-item-object-custom current-menu-item menu-item-172 fusion-dropdown-submenu" ><a href="https://ehpm.org/regulatory-issues/#main-3" class="fusion-bar-highlight"><span>ART.8 REG.1925/2006</span></a></li><li id="menu-item-1371" class="menu-item menu-item-type-custom menu-item-object-custom current-menu-item menu-item-1371 fusion-dropdown-submenu" ><a href="https://ehpm.org/regulatory-issues/#main-4" class="fusion-bar-highlight"><span>NOVEL FOODS</span></a></li><li id="menu-item-1372" class="menu-item menu-item-type-custom menu-item-object-custom current-menu-item menu-item-1372 fusion-dropdown-submenu" ><a href="https://ehpm.org/regulatory-issues/#main-5" class="fusion-bar-highlight"><span>BREXIT HUB</span></a></li></ul></li><li id="menu-item-1318" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-has-children menu-item-1318 fusion-dropdown-menu" data-item-id="1318"><a href="https://ehpm.org/category/join-ehpm/" 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class="fusion-mobile-menu-icons"> <a href="#" class="fusion-icon fusion-icon-bars" aria-label="Toggle mobile menu" aria-expanded="false"></a> <a href="#" class="fusion-icon fusion-icon-search" aria-label="Toggle mobile search"></a> </div> <nav class="fusion-mobile-nav-holder fusion-mobile-menu-text-align-left" aria-label="Main Menu Mobile"></nav> </div> <div class="menu-mobile" style="display:none"> <div class="menu-mobile-row"> <div class="search-mobile"> <div class="search0mobile"> <img src="https://ehpm.org/wp-content/uploads/2020/02/search_mobile_icon.png" alt="search"/> </div> </div> <div class="login-mobile"> <a class="mlinks m-account" href="https://ehpm.org/members-area/"><img src="https://ehpm.org/wp-content/uploads/2020/02/login_mobile_icon.png" alt="login"/></a> </div> <div class="menu-burger"> <div id="nav-icon" class="white-color"> <span></span> <span></span> <span></span> <span></span> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div class="fusion-clearfix"></div> </header> <div id="sliders-container"> </div> <div class="avada-page-titlebar-wrapper"> <div class='page-title-wrapper'><div class="feature-img page-feature regulatory-issues"> <div style="background-image:url(https://ehpm.org/wp-content/uploads/2020/02/banner_regulatory.jpg)"></div> </div><div class="breadcrumbs-wrapper"> <div class="breadcrumbs-row"> <div><span><span><a href="https://ehpm.org/" >Home</a> | <span class="breadcrumb_last" aria-current="page">Regulatory Issues</span></span></span></div> </div> </div></div> </div> <main id="main" class="clearfix width-100"> <div class="fusion-row" style="max-width:100%;"> <section id="content" class="full-width"> <div id="post-167" class="post-167 page type-page status-publish has-post-thumbnail hentry"> <span class="entry-title rich-snippet-hidden">Regulatory Issues</span><span class="vcard rich-snippet-hidden"><span class="fn"><a href="https://ehpm.org/author/admin/" title="Posts by admin" rel="author">admin</a></span></span><span class="updated rich-snippet-hidden">2021-11-22T18:52:08+02:00</span> <div class="post-content"> <div id="rg1" class="fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-ie-mode w1196 hundred-percent-fullwidth non-hundred-percent-height-scrolling" style='background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:15px;padding-bottom:68px;padding-left:15px;'><div class="fusion-builder-row fusion-row "><div class="fusion-layout-column fusion_builder_column fusion_builder_column_1_1 fusion-builder-column-0 fusion-one-full fusion-column-first fusion-column-last 1_1" style='margin-top:0px;margin-bottom:0px;'><div class="fusion-column-wrapper" style="padding: 0px 0px 0px 0px;" data-bg-url=""><ul class="tab-main"> <li class="tab-link-main active-main" data-tab="main-1">Mutual Recognition</li> <li class="tab-link-main" data-tab="main-2">Health Claims</li> <li class="tab-link-main" data-tab="main-3">Art.8 Regulation (EC) 1925/2006</li> <li class="tab-link-main" data-tab="main-4">Novel Foods</li> <li class="tab-link-main" data-tab="main-5">Brexit Hub</li> </ul><div class="fusion-clearfix"></div><div class="fusion-column-wrapper" style="content:'';z-index:-1;position:absolute;top:0;right:0;bottom:0;left:0;background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;" data-bg-url=""></div></div></div><div id="main-1" class="fusion-layout-column fusion_builder_column fusion_builder_column_1_1 fusion-builder-column-1 fusion-one-full fusion-column-first fusion-column-last tab-content-main active-main 1_1" style='margin-top:0px;margin-bottom:0px;'><div class="fusion-column-wrapper" style="padding: 0px 0px 0px 0px;" data-bg-url=""><div class="fusion-text"><p>The Mutual Recognition Principle ensures market access for goods that are not, or are only partly subject to EU harmonisation legislation. It guarantees that any good lawfully sold in one EU country can be sold in another. This is possible even if the good does not fully comply with the technical rules of the other country.</p> <p>The principle stems from Articles 34-36 of the Treaty on the Functioning of the European Union (TFEU) and is further defined in Regulation (EU) 2019/515 on the mutual recognition of goods lawfully marketed in another country. Regulation 2019/515 applies from 19 April 2020 and replaces Regulation (EC) No 764/2008. It defines the rights and obligations in relation to the mutual recognition principle for competent authorities and businesses when selling goods in another EU country.</p> <p>EHPM contributed to the process that led to the definition of the new Mutual Recognition Regulation. EHPM counts on the new Mutual Recognition Regulation to simplify and speed the application of the Mutual Recognition principle through the simplification of bureaucratic procedures will, thus facilitating the intra-community marketing of food supplements. At the same time, EHPM counts on the strengthened SOLVIT procedure as tool for resolving disputes raising from cases of failed implementation of the Mutual Recognition principle.</p> <p>EHPM is committed to disseminate, across the food supplement sector through dedicated events and publications, detailed knowledge of the procedures envisaged by the new Mutual Recognition Regulation. Indeed, EHPM believes that this knowledge is essential for companies in order to have the necessary tools to invoke the principle of mutual recognition.</p> </div><div class="fusion-clearfix"></div><div class="fusion-column-wrapper" style="content:'';z-index:-1;position:absolute;top:0;right:0;bottom:0;left:0;background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;" data-bg-url=""></div></div></div><div id="main-2" class="fusion-layout-column fusion_builder_column fusion_builder_column_1_1 fusion-builder-column-2 fusion-one-full fusion-column-first fusion-column-last tab-content-main 1_1" style='margin-top:0px;margin-bottom:0px;'><div class="fusion-column-wrapper" style="padding: 0px 0px 0px 0px;" data-bg-url=""><div class="fusion-text"><h2>What is a health claim?</h2> <p>A health claim is a descriptor of the beneficial physiological effect of a nutrient on the human organism. Health claims are used for the promotion of products to consumers via all means of commercial communications.</p> <h2>What is the Relevant Legislation?</h2> <p>Regulation (EC) No 1924/2006 on Nutrition and Health Claims made on foods (NHCR) governs the use of such claims in labelling, presentation and advertising. In its Preamble, the NHCR aspires to facilitate informed choice, alongside the protection of consumers and the encouragement of legitimate business in the food industry. However, an inappropriate demand for medical-style scientific proof has resulted in an impractical authorization process that is alien to the culture of the food industry and beyond its expertise and resources. As a result, only a small number of the more than 4000 health claims identified on the market have been authorised by EFSA (European Food Safety Authority). Consequently, more than 2000 botanicals health claims have been put “on hold”.</p> <p>The effect is that consumers do not have access to the information that they are increasingly looking for on the health benefits of the foods, and particularly the food supplements, that they purchase. As a consequence, consumers are increasingly turning to uncontrolled sources for information, such as the internet – increasing the likelihood of them being misled. Furthermore, this regulatory uncertainty discourages food supplement companies from investing in innovation.</p> <h2>The Current Situation: The REFIT of the NHCR</h2> <p>In May 2015, the European Commission announced its plan to carry out a REFIT evaluation of the NHCR in order to find a solution to this situation. The term ‘REFIT’ refers to the European Commission’s regulatory fitness and performance programme and is an evaluation which is designed to ensure that laws remain simple and that unnecessary or obsolete legislation can be adapted or removed where appropriate.</p> <p>In June 2020, the European Commission published the Staff Working document on the evaluation of the NHCR in which the Commission acknowledged that the objectives of the NHCR are not fully attained.</p> <p>The European Commission Staff Working Document concluded that:</p> <ul> <li>it could be appropriate to explore the notion of “traditional use” in the efficacy assessment of health claims on botanicals used in foods together with the effects of the co-existence, on the EU market, of traditional herbal medicine products (THMPs) on the same botanicals.</li> <li>there are merits for further studying the potential EU harmonisation of the field of plants, including the safety aspect.</li> </ul> <p>EHPM noted that:</p> <ul> <li>the European Commission recognised the importance of tradition of use in efficacy assessment of health claims on botanicals used in foods. However, EHPM argues that tradition of use only is not enough. EHPM proposes to adapt the current process applied by EFSA to the over 2,000 botanical health claims that are on-hold by using a graded approach, which reflects the evidence for the claim in the wording and goes beyond tradition to improve innovation in the food supplements sector.</li> <li>the evaluation, although health claims assessment was the main topic, made repeated reference to safety concerns regarding botanicals used in food supplements. Alarmingly, the European Commission recognised Art.8 of Regulation (EC) 1925/2006 is being used to draw a list of plants which use in foods is prohibited (negative list). The procedure and deadlines set out in Art. 8 are unsustainable in the long term for companies in the food supplement sector and will result in disproportionate measures. Finally, the fact that that Art.8 can be used when there is a potential risk will create a persistent uncertainty which will hinder investments and innovation.</li> </ul> <h2>EHPM proposal for a Graded-Approach to Botanicals Health Claims</h2> <p>EHPM has been working on a balanced solution, that would address the requirement for scientific stringency, be practical for the industry and above all else provide consumers with the sort of information that they are looking for on the foods that they purchase and eat: a Graded Approach to Botanicals Health Claims in Food Supplements.</p> <p>The approach has been developed to be consistent with both the fundamental requirements of the NHCR and the systematic procedures already adopted by EFSA.</p> <p>Three types of graded health claim are identified:</p> <ol> <li><strong>Scientifically established health claims, similar to those already authorized by EFSA:</strong></li> <li><strong>Scientifically well supported health claims based on significant developments in modern science and experience.</strong></li> <li><strong>Traditional use health claims that have been used for at least one generation and which are considered to be scientifically plausible.</strong></li> </ol> <p><img loading="lazy" class="alignnone wp-image-1324" src="https://ehpm.org/wp-content/uploads/2020/12/Screenshot-2020-12-14-at-11.18.27-PM-300x129.png" alt="" width="398" height="171" srcset="https://ehpm.org/wp-content/uploads/2020/12/Screenshot-2020-12-14-at-11.18.27-PM-200x86.png 200w, https://ehpm.org/wp-content/uploads/2020/12/Screenshot-2020-12-14-at-11.18.27-PM-300x129.png 300w, https://ehpm.org/wp-content/uploads/2020/12/Screenshot-2020-12-14-at-11.18.27-PM-400x173.png 400w, https://ehpm.org/wp-content/uploads/2020/12/Screenshot-2020-12-14-at-11.18.27-PM-600x259.png 600w, https://ehpm.org/wp-content/uploads/2020/12/Screenshot-2020-12-14-at-11.18.27-PM-768x331.png 768w, https://ehpm.org/wp-content/uploads/2020/12/Screenshot-2020-12-14-at-11.18.27-PM-800x345.png 800w, https://ehpm.org/wp-content/uploads/2020/12/Screenshot-2020-12-14-at-11.18.27-PM.png 890w" sizes="(max-width: 398px) 100vw, 398px" /></p> <p>The EHPM Paper “Botanical Health Claims on Foods & Food Supplements in the EU” in which the EHPM Proposal for a Graded Approach to Botanicals Health Claims in Food Supplements is presented and its Briefing Paper are accessible <strong><a href="https://ehpm.org/news/january-2021-ehpm-proposal-on-botanicals-health-claims/" target="_blank" rel="noopener noreferrer">HERE</a></strong>!</p> </div><div class="fusion-clearfix"></div><div class="fusion-column-wrapper" style="content:'';z-index:-1;position:absolute;top:0;right:0;bottom:0;left:0;background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;" data-bg-url=""></div></div></div><div id="main-3" class="fusion-layout-column fusion_builder_column fusion_builder_column_1_1 fusion-builder-column-3 fusion-one-full fusion-column-first fusion-column-last tab-content-main 1_1" style='margin-top:0px;margin-bottom:0px;'><div class="fusion-column-wrapper" style="padding: 0px 0px 0px 0px;" data-bg-url=""><div class="fusion-text"><h2>What is it?</h2> <p>The addition of vitamins and minerals and other substances to foods is regulated by Regulation (EC) 1925/2006. Art.8 of Regulation (EC) 1925/2006 is particularly relevant for the food supplement sector and its use in recent years has been subject of controversy.</p> <p>Art.8 of Reg. EC 1925/2006 provides the procedure to be followed where a substance other than vitamins or minerals, or an ingredient containing a substance other than vitamins or minerals, is added to foods or used in the manufacture of foods under conditions that would result in the ingestion of amounts of this substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers.</p> <h2>What is the challenge?</h2> <p>The European Commission identifies Art.8 of Regulation (EC) 1925/2006 as the legislative tool to be used to establish a list of plants and other ingredients whose use is prohibited in food supplements. This fact is of great concern for the entire sector since, as EHPM have highlighted multiple times, the Art.8 procedure and its timelines are extremely stringent for the industry and disproportionate for the consumer. Also in the absence of a dialogue with EFSA, and of an appropriate safety assessment method for botanicals, it is extremely challenging for companies to have clarity on the type of data they will need to submit to substantiate the safety of the ingredient under assessment. This process is therefore unsustainable for the food supplement sector in the long term.</p> <h2>EHPM’s proactive approach</h2> <p>EHPM monitors the European Commission’s initiatives and is in constant contact with Officials from the European Commission. EHPM activates its network of companies and experts whenever the European Commission is about to launch a new Art.8 procedure for a substance or a mixture. On a case by case basis, EHPM can decide to formalise its experts group addressing the Art.8 procedure by establishing an ad hoc task force. This was the case of the Task Force on Monacolins from Red Yeast Rice.</p> <p>Through the Task Force on Monacolins from Red Yeast Rice, EHPM aims at establishing and promoting industry best practices for food supplements quality, safety, and efficacy. In this framework, EHPM members set up a European alliance of food supplement companies across Europe willing to develop and implement a self-regulation manifesto, built on best practices already in place in some European countries, with the objective to set a golden standard within the industry.</p> <p>The manifesto is based on the following three pillars:</p> <ul> <li><strong>Ensuring safety and nutri-vigilance;</strong></li> <li><strong>Prioritising consumers’ awareness;</strong></li> <li><strong>Securing the implementation of manufacturing golden standards.</strong></li> </ul> <p>The work done by this ad hoc task force concerns food supplements containing Monacolins from Red Yeast Rice. However, the manifesto is a pilot approach that can potentially be applied to other substances or mixtures used in food supplements.</p> </div><div class="fusion-clearfix"></div><div class="fusion-column-wrapper" style="content:'';z-index:-1;position:absolute;top:0;right:0;bottom:0;left:0;background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;" data-bg-url=""></div></div></div><div id="main-4" class="fusion-layout-column fusion_builder_column fusion_builder_column_1_1 fusion-builder-column-4 fusion-one-full fusion-column-first fusion-column-last tab-content-main 1_1" style='margin-top:0px;margin-bottom:0px;'><div class="fusion-column-wrapper" style="padding: 0px 0px 0px 0px;" data-bg-url=""><div class="fusion-text"><p>Coming Soon!</p> </div><div class="fusion-clearfix"></div><div class="fusion-column-wrapper" style="content:'';z-index:-1;position:absolute;top:0;right:0;bottom:0;left:0;background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;" data-bg-url=""></div></div></div><div id="main-5" class="fusion-layout-column fusion_builder_column fusion_builder_column_1_1 fusion-builder-column-5 fusion-one-full fusion-column-first fusion-column-last tab-content-main 1_1" style='margin-top:0px;margin-bottom:0px;'><div class="fusion-column-wrapper" style="padding: 0px 0px 0px 0px;" data-bg-url=""><div class="fusion-text"><p>The United Kingdom’s withdrawal from the EU, the Single Market and the Customs Union, created barriers to trade and cross-border exchanges that did not exist prior to 1 January 2021. Consequences for businesses were unavoidable, broad and far-reaching, even with the EU-UK Trade and Cooperation Agreement in place (accessible <strong><a href="https://ec.europa.eu/info/strategy/relations-non-eu-countries/relations-united-kingdom/eu-uk-trade-and-cooperation-agreement_en">here</a></strong>).</p> <p>These changes are unavoidable and companies must make sure they are ready for them. That is why EHPM is in contact with the responsible Officials from the European Commission and will provide its members with the latest updates on the duties companies will have to comply to. The insights, analyses and detailed reports are available for members in the dedicated section of the members’ area.</p> </div><div class="fusion-clearfix"></div><div class="fusion-column-wrapper" style="content:'';z-index:-1;position:absolute;top:0;right:0;bottom:0;left:0;background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;" data-bg-url=""></div></div></div></div></div> </div> </div> </section> </div>  </main>  <div class='top-wrapper'><div class='top-row'><svg xmlns="http://www.w3.org/2000/svg" width="19.519" height="37.816" viewBox="0 0 19.519 37.816"> <g id="Group_38" data-name="Group 38" transform="translate(-89.94 -1170.684)"> <path id="Path_1" data-name="Path 1" d="M1076-83h12.3v12.305" transform="translate(-611.157 2001.039) rotate(-45)" fill="none" stroke="#ffcc02" stroke-width="3"/> <line id="Line_58" data-name="Line 58" y2="35" transform="translate(99.701 1173.5)" 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