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 foods 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.
It is noted that the Implementing Regulation laying down the procedural steps of the consultation process for determination of novel food status has not yet been published. This is foreseen in the course of March 2018. The guidance document will then be updated to include this act.

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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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Risk management approaches to the setting of maximum levels of vitamins and minerals in food supplements for adults and for children aged 4-10 years

This publication reviews the application of the principles of risk management for the setting of maximum levels of vitamins and minerals in food supplements for adults and for children aged 4–10 years by taking into account the tolerable upper intake levels (ULs) derived from international risk assessments and the contributions to total intake from conventional foods, fortified foods and food supplements. The proposed maximum levels for food supplements (MLS) have been defined to balance the risk of deficiency with risk of overconsumption and to avoid that cumulative intake leads to any adverse effects in the population, including sensitive groups such as children, the elderly and women during pregnancy and lactation.

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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 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

This report intends to provide clarity on a number of aspects to help companies apply the regulatory requirements in a correct and responsible way. It covers elements such as which claims fall within the scope of the legislation, flexibility of wording, communication to professionals and how to apply the general conditions of use for approved claims. The information will help companies, in particular small and medium-sized companies, to apply those elements of the legislation that are particularly difficult.

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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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