MINERALS
VITAMINS
HERBS & EXTRACTS
PROBIOTICS
Nutrition

To protect consumers against potential health risks arising from the consumption of food supplements and to ensure that they are not provided with misleading information, food supplements are covered by European and national laws and regulations on food safety.

FREQUENTLY ASKED QUESTIONS

Food supplements are concentrated sources of nutrients (i.e. mineral and vitamins) or other substances with a nutritional or physiological effect that are marketed in “dose” form (e.g. pills, tablets, capsules, liquids in measured doses). Food supplements are intended to correct nutritional deficiencies, maintain an adequate intake of certain nutrients, or to support specific physiological functions. They are not medicinal products and as such cannot exert a pharmacological, immunological or metabolic effect.

Food supplements are only intended to ‘supplement’ people’s diets and not replace healthy foods.  The regulation of food supplements makes clear that food supplements are not intended to replace a varied and balanced diet and food supplements packaging is required to state this information.

Because food supplements are considered as food, it is the responsibility of the manufacturer, importer, supplier or distributor to ensure that a food supplement placed on the market is safe.

EU Member States may, for monitoring purposes, request notification of the placing on the market in their territory of a food supplement. Once the product is on the market, the competent authority of the Member State may monitor its use and safety in that territory.

Following an assessment by the European Food Safety Authority (EFSA), the European Commission may take a decision to include a certain substance in a list of substances whose use in foods is prohibited, restricted or under scrutiny. This may happen when the addition of a substance in food products increases its exposure to levels greatly exceeding the normal consumption and/or poses a potential risk to consumers.

Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 partially harmonizes the rules for placing food supplements on the European market. The scope of the Directive includes all food supplements with certain requirements, in particular those relating to labeling particulars, which apply to all food supplements, whatever their composition.

INDUSTRY NEWS & UPDATES

BREXIT e os Produtos Cosméticos Comercializados em Portugal

No passado dia 22 deste mês, o INFARMED, I.P., emitiu uma Circular Informativa, onde concede um período transitório de 6 meses às empresas, cuja Pessoa Responsável está sediada no Reino Unido e que desejam continuar a ter os seus produtos cosméticos disponíveis no mercado nacional, para que possam enviar toda a documentação e informação necessárias.

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Virginia – The Fourth State to Ban Animal Testing in the U.S.

In the United States (U.S.), Virginia is the fourth state to ban animal testing in cosmetic products. The Governor of this state (Ralph Northam) has signed this month (March 2021) a bill and the ban will start on January 1st, 2022. The sale of cosmetics tested on animals will also be prohibited from July 1st, 2022.

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France Anti-Waste Law

On February 11th, 2020, the Loi relative à la lute contre le gaspillage et a l’économie circulaire (Anti-Waste for a circular economy) has come officially into force in France. The law provides for a ban on all single-use plastics by 2040.

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EU Reduction of the Impact of Certain Plastic Products on the Environment

Cosmetics and personal care industry are a growing business, but with this growth comes a major concern: plastic pollution.
The European Commission has published the Directive (EU) 2019/904, known as Single-Use Plastic Directive. This directive addresses the reduction of the impact of certain plastic products on the environment. Harmonized marking specifications are laid down on the Commission Implementing Regulation (EU) 2020/2151.

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BREXIT – Impact on Medical Devices placed in the UK market

From 31 of December 2020, the UK will be regarded as a third country and not a Member State of the European Union. There will be some changes regarding medical devices placed in the UK. The UK’s MHRA has published guidance regarding the regulation of medical devices from 1 January 2021, where it explains what changes and what there is to know about placing a medical device in the Great Britain, Northern Ireland and EU markets.

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Brazil – Class II Medical Devices – New Resolution

A new Resolution of the Collegiate Board of Directors (RDC No. 423/2020) has been published by Brazil’s National Agency of Health Surveillance (ANVISA). This new Resolution announces the elimination of the ‘Cadastro’ pathway regarding the registration of medical devices (Class II) and IVDs, substituting it with a notification registration system.

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