Food Supplements Europe

FOOD SUPPLEMENTS EUROPE GUIDELINES RELATING TO THE MANUFACTURING AND IMPORTS OF FOOD SUPPLEMENTS CONTAINING PRODUCTS OF ANIMAL ORIGIN, WITH A PARTICULAR FOCUS ON VITAMIN D3

The requirements for the import of Vitamin D3 into the EU have changed.

These guidelines are intended to help food business operators to understand this new environment and the rules that are applying to imports of vitamin D and products containing Vitamin D.

Since the rules differ depending on whether a product is a Product of Animal Origin or a Composite Product, these guidelines also provide clarity on how to assess if a product is a Composite Product.

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RISK MANAGEMENT APPROACHES TO THE ESTABLISHMENT OF MAXIMUM LEVELS OF VITAMINS AND MINERALS IN FOOD SUPPLEMENTS FOR ADULTS AND FOR CHILDREN AGED 4-10 YEARS

This updated fourth edition of the risk management model for the setting of maximum levels of vitamins and minerals in food supplements for adults and for children aged 4–10 years has been developed for use by government risk managers and the food supplement sector. It takes into account the tolerable upper intake levels (ULs) derived from international risk assessments, the highest intake contributions to total intake from conventional foods, fortified foods and food supplements and a number of assumptions to account for potential increases of intake over time.

The proposed maximum levels for food supplements (MLS) have been defined to ensure that intake of vitamins and minerals from food supplements is safe and balances the risk of deficiency with the risk of overconsumption. Levels are proposed for the adult population and for children. To encompass various scenarios of intake, the model integrates a number of conservative assumptions including the use of the 97.5th percentile of intake and an additional safety factor to account for potential future increases in intake of vitamins and minerals.

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PROBIOTICS: GROWING SCIENCE AND NEED FOR PROPER CONSUMER COMMUNICATION ON PROBIOTIC FOOD SUPPLEMENTS

Scientific research on probiotics continues to grow worldwide. In 2020 alone, over 4,300 publications were devoted to probiotics. This report gives an overview of the many meta-analyses and systematic reviews that have been published over the last 5 years, highlighting the various benefits of probiotics for health. It aims is to stimulate renewed dialogue about the use of the term probiotics for supplements in the European Union.

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GUIDELINES ON HOW TO APPLY THE NEW MUTUAL RECOGNITION REGULATION (EU) 2019/515 TO FOOD SUPPLEMENTS IN THE EU

One of the key achievements of the European Union (EU) is the principle of ‘Mutual Recognition’. This enables companies to place a product that is lawfully marketed in one Member State on the market in all other Member States irrespective of national legislation in place.

Nevertheless, as many economic operators in the area of food supplements have experienced, in practice the application of Mutual Recognition is far less straight forward. It is not well understood by companies and is often not applied correctly by Member States.

In 2019 the European Commission therefore adopted Regulation (EU) 2019/515, with application starting on 19 April 2020.

Food Supplements Europe has developed guidelines to explain the main principles of that legislation with a specific focus on how to apply them to food supplements, highlighting the do’s and don’ts and providing guidance on the problem-solving procedure. It is intended for everyone involved in helping make the mutual recognition procedure work efficiently across the EU.

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GUIDANCE ON THE OBLIGATION OF ORIGIN LABELLING WITH REGARD TO “PRIMARY INGREDIENTS OF DIFFERENT ORIGIN” FOR FOOD SUPPLEMENTS

Indicating the Country of Origin (COOL) or Place of Provenance (POP) of a food supplement is voluntary. Regulation 2018/775 imposes specific requirements to meet in case the COOL or POP of the food is not the same as that of its primary ingredient(s). Food Supplements Europe has developed guidance on how to apply this to food supplements. It provides information on how to establish the primary ingredient of a food supplement and how to indicate its origin.

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GUIDELINES AND RECOMMENDATIONS TO REDUCE THE PRESENCE OF PYRROLIZIDINE ALKALOIDS IN FOOD SUPPLEMENTS

Maximum levels for the presence of pyrrolizidine alkaloids have been set by the European Commission for food supplements in Regulation (EU) 2020/2040. They will apply from 1 July 2022. Compliance with these limits requires efforts across the supply chain to help growers and collectors of botanicals to recognise PA-producing weeds and put in place systems and apply practices to avoid their presence in their harvests. Food Supplements Europe has developed these guidelines to help all actors in the supply chain to prepare for these levels and identify measures that are required to ensure that the accidental presence of pyrrolizidine alkaloids in food supplements is kept as low as technically possible.

The second edition of the guidance document was published in May 2021. It updates the legal reference to the Regulation and takes into account experience gathered since the first publication of this guidance.

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GUIDANCE FOR FOOD BUSINESS OPERATORS ON THE VERIFICATION OF THE STATUS OF A NEW FOOD UNDER THE NEW NOVEL FOODS REGULATION 2015/2283 (NFR)

The Novel Foods Regulation 2015/2283 and its Implementing Regulations 2017/2468 (novel foods from a third country), 2017/2469 (novel foods requirements) and 2017/2470 (Union list of novel foods) take full effect from 19 January 2018.

With this legislation, it becomes a legal obligation for food business operators to verify whether a new food falls under the scope of the novel food definition and in case of uncertainty to consult a Member State authority.

The aim of these guidelines is to help food business operators understand the scope of the new NFR and the principles to apply when verifying the status of their products. It focuses on all foods, including food supplements and ingredients thereof. Other European food associations have contributed to this work to ensure it covers all foods on the EU market.

The second edition of the guidance document was published in January 2019 and takes into account experience gathered during the first year of the application of the new Regulation.

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A summary of these guidelines for easy reference is available in A5 format. When printing this document, select “print as booklet“ from your print menu.

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GOOD MANUFACTURING PRACTICE FOR MANUFACTURERS OF FOOD SUPPLEMENTS

The aim of this document is to produce guidelines which address the specific needs of the food supplement industry in relation to good manufacturing practice, with special attention paid to the requirements of EU food legislation. It covers the complete cycle of production and quality control of a food supplement, from the acquisition of all materials through all stages of subsequent processing, packaging and storage to the distribution or release of the finished product. As such, relevant sections of the document apply also to food supplement companies whose products are contract manufactured and also to those who are solely distributors of products.

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A questionnaire is also available to assist companies with assessing their current GMP status and to highlight any areas where further efforts to raise the GMP standard may be required. If no external GMP assessment is undertaken, annual self-assessment of GMP is recommended, as a minimum.

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QUALITY OF BOTANICAL PREPARATIONS: RECOMMENDATIONS FOR THE MANUFACTURING OF BOTANICAL PREPARATIONS, INCLUDING EXTRACTS AS FOOD SUPPLEMENTS

This guidance is intended to complement the Food Supplements Europe Guide to Good Manufacturing Practice for Manufacturers of Food Supplements, specifically in relation to extracts. The quality of the preparation and consistency of production is particularly important where a quantitative or qualitative claim is made for a botanical for one or more of its constituents. This guidance covers the requirements necessary to ensure that the production of botanical preparations complies with the compositional and quality requirements of EU food law.

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A questionnaire has also been developed to assist food supplement manufacturers with assessing the quality of botanical preparations when selecting their raw materials and to highlight areas where further information may need to be requested from the supplier.

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GUIDELINES FOR THE SUBSTANTIATION OF BEAUTY CLAIMS FOR FOOD SUPPLEMENTS

These guidelines are intended to assist food operators in the proper use of beauty claims that do not fall under the scope of the Nutrition and Health Claims Regulation (NHCR – Regulation 1924/2006). They cover specifically the way to generate data to support the use of such claims for food supplements.

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SETTING OF TOLERANCES FOR NUTRIENT VALUES DECLARED ON A LABEL

This guidance document is intended to assist food supplement companies in setting tolerances for nutrition labelling of food supplements under Directive 2002/46/EC and Regulation (EC) No 1924/2006 on nutrition and health claims made on foods.

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THE APPLICATION OF THE NUTRITION AND HEALTH CLAIMS REGULATION 1924/2006

These guidelines are intended to assist food operators when applying the principles and requirements of the Nutrition and Health Claims Regulation 1924/2006 (NHCR).

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FACTS ABOUT VITAMINS, MINERALS AND OTHER FOOD COMPONENTS WITH HEALTH EFFECTS

Research has demonstrated that nutrients and other food components play an important role in the maintenance of health. This report provides detailed information on the role of these food components in the body, their use and safety.

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