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Growing internationally: languages, country rules and Switzerland in direct selling
Novogenia has partners in 69 countries and delivers reports in up to 18 languages – the analysis and products travel easily, the rules do not. Before launching in any country, check who may order which analysis, which language the label needs, which advertising claims apply and how genetic data are protected. Distributors everywhere offer non-medical analyses only; medical analyses remain reserved for physicians in countries such as Austria, Germany, Switzerland and the USA (in Austria with one exception: pharmacogenetics). In Switzerland, even lifestyle analyses may only be ordered by certain health professionals, and home self-tests are not permitted for them.
One lab, 69 countries
One lab in Eugendorf near Salzburg, partners in 69 countries, reports in up to 18 languages: genetic analyses and personalized products travel easily. A saliva sample fits in an envelope, the report arrives digitally via a secure portal, and the box of daily servings goes straight to the customer.
What does not automatically travel along are the rules. Imagine your offer needs its own passport at every border, with several stamps: May this analysis be sold here – and by whom? Which language must be on the label? Which advertising claim applies? How are genetic data protected? This article shows you which stamps you need before launching in a new country – with a close look at Switzerland, where the rules differ markedly from the EU.
| Area | Travels along | Check for each country |
|---|---|---|
| Analysis | one lab in Austria, analysis in 4 days | who may order the analysis and how the sample is collected |
| Report | digital, in up to 18 languages | whether your market’s language is included |
| Supplements | formula, Microtransporters, direct shipping | label language, notification, authorized claims |
| Cosmetics | three BeautyMe products, responsible person in the EU | label language; separate rules outside the EU |
| Training | NOVO Academy in seven languages | country rules for your team |
| Data | secure portal | the country’s data protection law |
Languages: report, label, training
A network grows through conversations – and conversations need the customer’s language. So plan each level separately:
- Reports: in up to 18 languages, digital and printed on request. We clarify before launch which languages your market needs.
- Supplement labels: Mandatory information must appear in a language easily understood by consumers in the member state where the product is marketed. Member states can require one or more official languages of the Union, and multilingual labels are allowed (Art. 15 Regulation (EU) No 1169/2011).
- Cosmetics labels: The language for information such as nominal content, date of minimum durability, precautions and function is determined by the law of the member state where the product is made available to end users (Art. 19(5) Regulation (EC) No 1223/2009).
- Advertising claims: The list of authorized health claims (Regulation (EU) No 432/2012) is available in the official languages of the EU. Use the official wording of your language instead of translating it yourself – otherwise every translation turns into a game of telephone.
- Training: The NOVO Academy is available in German, English, Czech, French, Portuguese, Italian and Dutch. For other languages, plan your own materials – and have the translated copy blocks legally reviewed.
The most important line: medical or lifestyle
At Novogenia, the same basic rule applies in every country: distributors offer non-medical analyses only. Medical analyses are reserved for physicians wherever national law requires it – for example, in Austria, Germany, Switzerland and the USA. Exactly where the line runs is up to each country:
| Country | What applies | Legal basis |
|---|---|---|
| Germany | The act covers genetic testing for medical purposes, for clarifying parentage, and in insurance and employment. Diagnostic testing may only be performed by physicians, predictive testing only by specialists in human genetics or correspondingly qualified physicians. | Sections 2(1) and 7(1) of the Genetic Diagnostics Act (GenDG) |
| Austria | Analyses of a predisposition to a disease or of carrier status (types 3 and 4) only in approved facilities and when ordered by a specialist in human genetics/medical genetics or a specialist for the relevant indication. | Sections 65(1) and 68(1) of the Gene Technology Act (GTG) |
| Switzerland | Even analyses on nutrition, sport and well-being only through certain health professionals; sample collected in their presence; no self-tests for them. | Art. 13, 31 and 34 GUMG; Art. 37 and 40 GUMV |
| USA | Novogenia provides medical analyses only through physicians. | check before launch |
| Other countries | Check the rules before launch – with us and a local expert. | national law |
The details for Germany, Austria and Switzerland are explained in Who may offer genetic tests? Pharmacogenetics – analyses of how the body responds to medications – is a separate field with its own rules; more in the Pharmacogenetics guide.
Switzerland: three questions instead of one
In Germany and Austria, almost everything hinges on one question: medical or not? Switzerland asks two more: Who orders the analysis – and where is the sample collected? The Federal Act on Human Genetic Testing (GUMG) expressly regulates analyses outside medicine as well, and the related ordinance (GUMV) spells them out:
- Lifestyle is “particularly sensitive”: Analyses of physiological characteristics whose knowledge can influence a person’s lifestyle (Art. 31(1)(a) GUMG) cover in particular eating behavior, physical activity and general well-being (Art. 37(1) GUMV).
- Only certain professions may order: health professionals who are authorized to practice under their own professional responsibility and have acquired knowledge of human genetics (Art. 34(1) GUMG). The ordinance lists physicians, pharmacists, psychologists, druggists HF and – for physiological characteristics – nutritionists FH, physiotherapists FH, chiropractors and osteopaths (Art. 40 GUMV).
- Sample in their presence: The sample must be collected in the presence of the person ordering the analysis (Art. 34(3) GUMG).
- No self-tests: Tests for self-use may only be supplied for the remaining analyses, such as hair or eye color (Art. 13 GUMG, Art. 37(3) GUMV).
- Some topics are always medical: Analyses on matters such as food intolerances, metabolic disorders or an increased risk of sports injuries count as medical (Art. 37(2) GUMV).
- Advertising with mandatory information: Advertising these analyses to the public must, among other things, inform about the rules on ordering, information and communication of the result; misleading statements are prohibited (Art. 14(3) GUMG).
What this means for your network: A distributor in Switzerland who does not belong to these professions cannot order the genetic analysis herself and cannot hand out a kit for sampling at home. The route leads through an authorized health professional who orders the analysis and is present when the sample is collected.
Supplements and cosmetics are separate questions under Swiss law of their own. Health claims are only allowed there if they are provided for in Annex 14 of the FDHA Ordinance on Food Information (LIV) (Art. 31(2) LIV) – the EU list does not apply directly in Switzerland. What is different for cosmetics in Switzerland is covered in Responsible person, safety assessment, notification.
Supplements and cosmetics in the EU
Within the EU, you have one big advantage: many rules are the same everywhere.
- Advertising claims: Health claims are only allowed if they are authorized and included in the list of authorized claims (Art. 10(1) Regulation (EC) No 1924/2006) – the same list in every member state.
- Notification: This differs from country to country. In Germany, for example, the manufacturer or importer notifies a food supplement to the Federal Office of Consumer Protection and Food Safety (BVL) at the latest when it is first placed on the market (Section 5 of the Food Supplements Ordinance, NemV). At Novogenia, we take care of the notification in most cases or guide you through it.
- Cosmetics: A cosmetic product may only be placed on the market if a person within the EU has been designated as the responsible person (Art. 4(1) Regulation (EC) No 1223/2009). Novogenia takes on this role – more in Your own brand for network companies.
Genetic data: data protection always travels along
Genetic data enjoy special protection. The GDPR defines them separately (Art. 4(13)) and counts them among the special categories of personal data whose processing is prohibited in principle – unless, for example, the person has given explicit consent (Art. 9(1) and (2)(a) Regulation (EU) 2016/679). In Switzerland, genetic data are sensitive personal data under the Federal Act on Data Protection (DSG) (Art. 5(c)(3) DSG). In addition, for analyses outside the medical field, the GUMG requires written information that names, among other things, the lab performing the analysis and the companies and labs abroad involved (Art. 32 GUMG).
Before launch, clarify who is the controller and who is the processor, and record in the consent who sees the reports. More in Genetic data and the GDPR.
A new country in six steps
- Check the analysis rules: Who may order which analysis? How is the sample collected? Are home kits allowed?
- Check the product rules: label language, notification and authorized claims – inside and outside the EU.
- Sort out the languages: report, label, copy blocks and training materials in the local language; authorized claims in their official wording.
- Adapt data protection: roles, information and consent under the law of the country.
- Train your team: The country rules belong in your training – see Training your distributors.
- Start small: Test with a pilot group, then roll out – see Launch: pilot and scaling.
Whether and how we deliver to your target market is something we clarify in our first conversation. The legal basics for claims and genetic tests are summarized in Law in direct selling: claims and genetic tests.
Frequently asked questions
In which countries is Novogenia active?
In which languages are the reports available?
May distributors in Switzerland offer genetic analyses?
Do authorized health claims apply in every country?
Does the label have to be in the local language?
Related: Who may offer genetic tests? · Genetic data and the GDPR · Notifying food supplements in the EU
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Request a project →Partner programNote: This guide is general information for businesses and professionals and does not replace medical or legal advice. The genetic traits determined in a genetic analysis are well documented (each gene included is backed by at least three independent studies); recommendations derived from them are logical conclusions, not scientifically proven. Regulations can change; errors and changes excepted.
