{"id":3302,"date":"2022-02-08T13:34:49","date_gmt":"2022-02-08T13:34:49","guid":{"rendered":"https:\/\/pharma-expertise.com\/labelling-and-mandatory-information"},"modified":"2022-11-04T20:08:07","modified_gmt":"2022-11-04T20:08:07","slug":"labelling-and-mandatory-information","status":"publish","type":"page","link":"https:\/\/pharma-expertise.com\/en\/labelling-and-mandatory-information\/","title":{"rendered":"Labelling &#038; Mandatory Information"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; fullwidth=&#8221;on&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_fullwidth_image src=&#8221;https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/10\/top_pharma-nahrungsergaenzungsmittel-min.jpg&#8221; alt=&#8221;Pharma &#038; Dietary Supplements&#8221; title_text=&#8221;Dietary Supplements&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_fullwidth_image][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.16&#8243; custom_margin=&#8221;||0px||false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;4.18.1&#8243; text_font=&#8221;||||||||&#8221; text_line_height=&#8221;2em&#8221; header_font=&#8221;Manrope|600|||||||&#8221; header_text_color=&#8221;#20292f&#8221; header_font_size=&#8221;26px&#8221; header_line_height=&#8221;1.3em&#8221; header_2_font=&#8221;Manrope|600||on|||||&#8221; header_2_text_color=&#8221;#193b7a&#8221; header_2_font_size=&#8221;14px&#8221; header_2_letter_spacing=&#8221;1px&#8221; header_2_line_height=&#8221;1.2em&#8221; header_3_font=&#8221;Manrope|500|||||||&#8221; header_3_font_size=&#8221;20px&#8221; header_3_line_height=&#8221;1.4em&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; hover_enabled=&#8221;0&#8243; header_2_font_size_tablet=&#8221;42px&#8221; header_2_font_size_phone=&#8221;32px&#8221; header_2_font_size_last_edited=&#8221;off|desktop&#8221; header_3_font_size_tablet=&#8221;28px&#8221; header_3_font_size_phone=&#8221;20px&#8221; header_3_font_size_last_edited=&#8221;on|phone&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<h2>Labelling &amp; Mandatory Information<\/h2>\n<h1>Labelling and mandatory information according to FDA and EU-regulation<\/h1>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.18.1&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Manrope||||||||&#8221; text_text_color=&#8221;#6d7c90&#8243; header_font=&#8221;Manrope|600|||||||&#8221; custom_margin=&#8221;0px||||false|false&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p>For the US market. we implement the labeling of your dietary supplements in compliance with the <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=101\"><strong>FDA CFR 21 Part 101 and <\/strong><\/a><a href=\"https:\/\/ods.od.nih.gov\/About\/DSHEA_Wording.aspx\"><strong>DSHEA.<\/strong><\/a>\u00a0<\/p>\n<p>For the <strong>European market<\/strong>, many regulations must be taken into account when <strong>labeling foods <\/strong>(food supplements, specialty foods): in particular, the <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/DE\/ALL\/?uri=celex%3A32006R1924\"><strong>EU Health Claim Regulation<\/strong><\/a>, <a href=\"https:\/\/www.efsa.europa.eu\/en\"><strong>EFSA,<\/strong><\/a>\u00a0 <strong>\u00a0<a title=\"LMIV\" href=\"https:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2011:304:0018:0063:de:PDF\" target=\"_blank\" rel=\"noopener\">provisions of the Food Information Regulation (LMIV, Regulation (EU) No. 1169\/2001)<\/a><\/strong> and the new Food Information Regulation or Prepackaging Regulation. They specify which mandatory information must be provided on the packaging of food supplements (e.g., list of ingredients, best-before date, or name of the manufacturer).<\/p>\n<p>Labeling, <strong>advertising statements<\/strong> and <strong><a title=\"Health Claim Regulation\" href=\"https:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2006:404:0009:0025:DE:PDF\" target=\"_blank\" rel=\"noopener\">health claims<\/a><\/strong> (nutrition and health claims about food) are also regulated under the <strong><a title=\"Health Claim Regulation\" href=\"https:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2006:404:0009:0025:DE:PDF\" target=\"_blank\" rel=\"noopener\">Health Claims Regulation <\/a>(EC) No. 1924\/2006<\/strong>. Such claims may only be made if they are approved under the Regulation. For many ingredients, the European Commission has published a positive list for permitted health claims in Regulation (EU) No. 432\/2012.<\/p>\n<p>Food supplements must also comply with <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/DE\/TXT\/PDF\/?uri=CELEX:32002L0046&amp;from=SK\"><strong>Directive 2002\/46\/EEC<\/strong> <\/a>(additional labeling elements), e.g. for information on the recommended intake (amount to be taken daily).<\/p>\n<p><strong>Mandatory labeling <\/strong>and <strong>health claims<\/strong> according to the <a href=\"https:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2011:304:0018:0063:en:PDF\"><strong>Health Claims Regulation<\/strong> and <strong>Regulation (EU) 1169\/2011<\/strong><\/a> are essential for the <strong>marketability of your product<\/strong>. In addition, Directive 2002\/46\/EC and the Food Supplements Regulation (NemV) must be checked with regard to further special requirements.<\/p>\n<p><strong>We are happy to support you with the labeling of your products and their product claims. Just contact us!<\/strong><\/p>\n<p>[\/et_pb_text][et_pb_button button_url=&#8221;\/en\/contact&#8221; button_text=&#8221;Make a consultation appointment&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; custom_button=&#8221;on&#8221; button_text_size=&#8221;13px&#8221; button_text_color=&#8221;#FFFFFF&#8221; button_bg_color=&#8221;#16918f&#8221; button_border_width=&#8221;4px&#8221; button_border_color=&#8221;#16918f&#8221; button_border_radius=&#8221;0px&#8221; button_font=&#8221;Manrope|||on|||||&#8221; button_icon=&#8221;&#x24;||divi||400&#8243; button_icon_color=&#8221;#FFFFFF&#8221; background_layout=&#8221;dark&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Labelling &amp; Mandatory Information Labelling and mandatory information according to FDA and EU-regulationFor the US market. we implement the labeling of your dietary supplements in compliance with the FDA CFR 21 Part 101 and DSHEA.\u00a0 For the European market, many regulations must be taken into account when labeling foods (food supplements, specialty foods): in particular, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"class_list":["post-3302","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Dietary supplements \u00bb Labeling CFR21 Part 101, EU Health Claims<\/title>\n<meta name=\"description\" content=\"We offer: Dietary supplement CFR 21 PART 101 \u2714 FDA dietary supplement registration \u2714 EU Health claims \u2714 EFSA \u2714 EU Regulation 1924\/2006 \u2794 Contact.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-expertise.com\/en\/labelling-and-mandatory-information\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dietary supplements \u00bb Labeling CFR21 Part 101, EU Health Claims\" \/>\n<meta property=\"og:description\" content=\"We offer: Dietary supplement CFR 21 PART 101 \u2714 FDA dietary supplement registration \u2714 EU Health claims \u2714 EFSA \u2714 EU Regulation 1924\/2006 \u2794 Contact.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pharma-expertise.com\/en\/labelling-and-mandatory-information\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Expertise Consulting\" \/>\n<meta property=\"article:modified_time\" content=\"2022-11-04T20:08:07+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/pharma-expertise.com\\\/en\\\/labelling-and-mandatory-information\\\/\",\"url\":\"https:\\\/\\\/pharma-expertise.com\\\/en\\\/labelling-and-mandatory-information\\\/\",\"name\":\"Dietary supplements \u00bb Labeling CFR21 Part 101, EU Health Claims\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pharma-expertise.com\\\/#website\"},\"datePublished\":\"2022-02-08T13:34:49+00:00\",\"dateModified\":\"2022-11-04T20:08:07+00:00\",\"description\":\"We offer: Dietary supplement CFR 21 PART 101 \u2714 FDA dietary supplement registration \u2714 EU Health claims \u2714 EFSA \u2714 EU Regulation 1924\\\/2006 \u2794 Contact.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/pharma-expertise.com\\\/en\\\/labelling-and-mandatory-information\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/pharma-expertise.com\\\/en\\\/labelling-and-mandatory-information\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/pharma-expertise.com\\\/en\\\/labelling-and-mandatory-information\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/pharma-expertise.com\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Labelling &#038; 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