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.

 

  • Food Supplement product registration/notification to the competent authorities.
  • Conformity Assessment and Formulation troubleshooting with an in-depth analysis of the product and its formulation, advising about whether it could be classified as a food supplement and which adjustments it may need to do to comply with the applicable legislation.
  • Labelling Review – product labels and packaging, creating easy to read instruction documents for compliance with labelling legislation.
  • Nutrition and Health claims analysis with advise on how the products can be legally marketed according to different countries and regulations.
  • Scientific substantiation of food supplement claims
  • Review of Advertising and Marketing to make sure they comply with Advertising Standards and Codes.
  • Prepare Novel Food applications, which require a pre-market safety assessment in the form of a Novel Food Application or the simplified procedure for ‘substantial equivalence’ foods. 

 

 

  • Global importation/exportation support;
  • Assistance in the preparation of technical and administrative documents for export to Europe and non-EU countries;
  • Custom clearance, Free Sale Certificate, Certificate of Origin;
  • Support to local requirements compliance.

 

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 – 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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Butylphenyl Methylpropional to be prohibited in cosmetics placed in the EU market

Butylphenyl Methylpropional, also known as Lilial, is a fragrance ingredient that has been used for years in several cosmetic and non-cosmetic products. Nevertheless, some concerns have been expressed regarding the use of this ingredient and its risk to consumers. According to an amendment to the CLP Regulation (Commission Delegated Regulation No. 2020/1182), Butylphenyl Methylpropional is now classified as toxic to reproduction (Repr. 1B – CMR 1B) and it shall be prohibited in cosmetic products from 1st March 2022.

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China Bans Microbeads In Cosmetics

On 16th January 2020, China’s National Development and Reform Commission (NDRC) issued the Notice [2020] No. 80, with the aim of prohibiting the use of microbeads in cosmetics and personal care products. More detailed information was given in the Notice [2020] No. 1146, issued by the NDRC on 10th July 2020.

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EU Medical Devices Regulation – Unique Device Identifier (UDI)

In 2017, two Regulations on medical devices (MDR) and in in vitro diagnostic medical devices (IVDR) entered into force in the European Union (EU), establishing a modernized and more robust EU legislative framework and safeguarding a better public health protection and patient safety. According to the these Regulations, the Unique Device Identifier (UDI) will be mandatory for all medical devices and in vitro medical devices.

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FDA updates on hand sanitizers safety for use

The U.S. Food and Drug Administration (FDA) has announced that it is providing a new laboratory testing method to assess the quality of finished hand sanitizers. Moreover, the FDA has issued a new press release on August 27th 2020, where it warns consumers about hand sanitizers packaged in food and drink containers. Earlier this month, the FDA expanded hand sanitizer warnings to include 1-propanol contamination.

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