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FAQ for report by HoA working group "Food Supplements"

The European Heads of Food Safety Agencies (HoA) unanimously adopted a list of critical substances at their meeting in Brussels today. This is based on a report by the HoA working group “Food Supplements” (HoA WG FS). In its report, the working group prioritized 12 substances and concludes that these 12 substances are suitable for legally binding regulation, based on their risks for human health.

Why did the HoA WG FS write this report?

The existing EU legislation already harmonises many of the requirements for food supplements. However, some remain in need of clarification. These include, in particular, maximum quantities and the use of “other substances”. In view of a uniform risk management approach in the EU, it is important to agree on a harmonized list of ‘other substances’ which should be prohibited or restricted in food supplements.

What criteria were used to classify and prioritize the substances?

The prioritization was carried out primarily on the basis of available information on possible risks, in particular on the basis of risk assessments by the Member States. In addition, information on market availability, rapid alert notifications (RASFF) and existing national regulations were taken into account. Novel substances are per se subject to a ban on placing on the market until they are authorized. Thus, they were generally not considered for inclusion in Annex III of the Fortified Food Regulation.

Does it mean that these substances may no longer be used in food once the report has been published? Do I, as a food business operator, need to remove food supplements with ingredient X from the EU market?

No. The working group proposes that the use of these substances should be regulated in a legally binding manner. The European Commission will finally decide whether these proposals will be implemented. However, food business operators are at all times responsible for the safety of their products and thus have to make sure that their products comply with EU and national food law.

When can a legally binding regulation be expected?

First of all, the European Commission (EU COM) must decide whether these substances should be subject to a legally binding regulation. If the EU COM decides that legally binding regulation is needed, the EU COM must then mandate the European Food Safety Authority (EFSA) to further examine the substances. Based on the EFSA's opinion, a procedure would consequently be initiated by the EU COM to include the substances in Annex III of the Fortified Food Regulation. Unfortunately, it is not possible to predict how much time will be needed for this process.

If there are legally binding regulations at some point, will these substances no longer be allowed to be used in foods at all?

This question cannot generally be answered. Decisions will be made on a case-by-case basis, grounded on the respective opinions of the European Food Safety Authority. It may be possible that some substances will be completely banned, others however may still be used with restrictions, e. g. up to a certain maximum amount, only in certain foods or only for limited consumer groups.

What will happen when the European Commission will decide that no legally binding regulation is needed for the proposed substances?

First of all, food business operators are at all times responsible for the safety of their products and have to make sure that their products comply with EU and/or national food law. The answer to this question depends on the presence of national legislation and the legal means of the national competent authorities. The substances could be added for example to national lists of forbidden substances in food supplements.

Who can I contact if I [as manufacturer/distributor] am unsure whether or how I can use the substances mentioned in food?

In Germany, the competent food control authorities of the federal states are responsible. You can also contact a food chemistry expert sworn in by the Chamber of Industry and Commerce (IHK) or cross-check experts authorized by the federal states.

The answer to this question will differ for each member state.

I take a food supplement with ingredient X. Should I stop taking this food supplement?

Food supplements are generally not needed for healthy people who already get sufficient nutrients through a varied diet. Only special consumer groups, such as pregnant women (folic acid and vitamin D) and elderly people (vitamin D) require an increased nutrient intake for certain substances. Additional consultation with a general practitioner is recommended.

What can I do when I experience health complaints after taking food supplements with ingredient X?

If you think that a food supplement is affecting your health, stop taking it and consult your general practitioner.