AMIX™ MELATONINE SLEEP FORMULA
Food supplement declared in France, decision dated 22 April 2026
AMIX™ MELATONINE SLEEP FORMULA is a food supplement declared in France. Status: déclaré en France, commercialisation possible : l'administration ne s'est pas opposée à la déclaration (ce n'est ni une autorisation ni une évaluation de sécurité). 1 point in its composition requires a check (prohibited substance, dose or novel food). 1 rule of use applies to its ingredients (limits and warnings).
- Brand
- not provided
- Food business operator placing the product on the market
- Amix Levante Sl
- Status
- Déclaré en France, commercialisation possible : l'administration ne s'est pas opposée à la déclaration (ce n'est ni une autorisation ni une évaluation de sécurité)
- Form
- Flacon
- Daily dose
- 60 ml
Declaration 362983, procedure Article 15. Compl'Alim, food supplement declarations (France), retrieved 23 October 2026.
Regulatory points
- Substance interdite
Griffonia simplicifolia (DC.) Baill.: dangerous plant prohibited in food in Belgium (list 1).
Source: Belgium, Royal Decree of 31 August 2021, plant lists (annex replaced on 30 January 2024), arrêté royal du 31 août 2021, annexe remplacée le 30 janvier 2024, liste 1, page PDF 73.
- Conditions légales
Valeriana officinalis L.: L'absence de valépotriates doit être prouvée par des rapports d'analyse. L'étiquetage doit comporter un avertissement déconseillant l'emploi aux enfants de moins de 12 ans.
Source: French orders of 9 May 2006 (nutrients), 24 June 2014 (plants) and 26 September 2016 (other substances), consolidated LEGI collection, arrêté du 24 juin 2014, annexe I.
Declared composition
Plants
| Plant | Part | Preparation | Per day |
|---|---|---|---|
| Melissa officinalis L. | Feuille | Poudre (de plantes séchées ou broyées) | 200 mg |
| Griffonia simplicifolia (DC.) Baill. | Graine | Poudre (de plantes séchées ou broyées) | 150 mg |
| Valeriana officinalis L. | Racine | Poudre (de plantes séchées ou broyées) | 125 mg |
| Passiflora incarnata L. | Parties aériennes | Poudre (de plantes séchées ou broyées) | 100 mg |
Substances
| Name | Per day |
|---|---|
| acide gamma-aminobutyrique | 495 mg |
| mélatonine | 1.9 mg |
Other active ingredients
| Name | Per day |
|---|---|
| Myo-inositol | not declared |
Vitamins and minerals
Compl'Alim does not publish vitamin and mineral doses. The references below help you read the product label: EFSAEuropean Food Safety Authority. safety limit for adults and maximum dose set in France per product (Order of 9 May 2006, not revised since November 2006).
| Declared form | Nutrient | EFSA limit, adults | Maximum dose in France |
|---|---|---|---|
| Chlorhydrate de pyridoxine | Vitamine B6 | 12 mg | 2 mg |
Additives
E960, E955, E211, E202, E330
Other ingredients
eau
List from the declaration, administrative decision dated (Compl'Alim, food supplement declarations (France)).
Has the product changed? Photograph the packaging.
This information reproduces the manufacturer's declaration to the administration (DGAL). It does not say whether the product is effective and does not replace advice from a doctor or pharmacist, particularly during pregnancy or when taking medication.
Official warnings (Health Canada)
Health Canada publishes warnings on these ingredients:
- Melissa officinalis L.
Read the warning, when it applies and the studies cited
LEMON BALM -MELISSA OFFICINALIS
Route of administration: Oral
Cautions and warnings
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are pregnant or breastfeeding (EMA 2014).
1 study cited in the text has no matching reference in the monograph (see the anomalies listed on the sources page).
When using this product exercise caution if you drive or use machinery as you may experience drowsiness (EMA 2014).
1 study cited in the text has no matching reference in the monograph (see the anomalies listed on the sources page).
Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
- Valeriana officinalis L.
Read the warning, when it applies and the studies cited
Valerian - VALERIANA OFFICINALIS
Route of administration: Oral
Cautions and warnings
Condition of application: All uses.
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are pregnant or breastfeeding (Mills et al. 2006; Blumenthal et al. 2003; Barnes et al. 2002).
3 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
When using this product avoid taking with alcohol or products that cause drowsiness (Brinker 2010; Gennaro et al. 2000).
2 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
When using this product exercise caution if you drive or use machinery as you may experience drowsiness (EMA 2016; ESCOP 2003; Bradley 1992).
3 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
Condition of application: Sleep aid.
Ask a health care practitioner/health care provider/health care professional/doctor/physician if sleeplessness persists continuously for more than 4 weeks (chronic insomnia) (EMA 2016; Berardi et al. 2002; Dipiro et al. 2002).
3 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
Condition of application: Restlessness/nervousness.
Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
- Passiflora incarnata L.
Read the warning, when it applies and the studies cited
PASSIONFLOWER -PASSIFLORA INCARNATA
Route of administration: Oral
Cautions and warnings
Condition of application: Sleep aid.
Ask a health care practitioner/health care provider/health care professional/doctor/physician if sleeplessness persists for more than 4 weeks (chronic insomnia) (Berardi et al. 2002: DiPiro et al. 2002).
2 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
Condition of application: Restlessness/nervousness.
Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
Condition of application: All uses.
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are pregnant or breastfeeding (EMA 2014).
1 study cited in the text has no matching reference in the monograph (see the anomalies listed on the sources page).
When using this product avoid taking with alcohol or products that cause drowsiness (EMA 2014; Brinker 2010).
2 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
When using this product exercise caution if you drive or use machinery as you may experience drowsiness (EMA 2014).
1 study cited in the text has no matching reference in the monograph (see the anomalies listed on the sources page).
Known adverse reactions
Stop use if hypersensitivity/allergy occurs (EMA 2014).
1 study cited in the text has no matching reference in the monograph (see the anomalies listed on the sources page).
- mélatonine
Read the warning, when it applies and the studies cited
MELATONIN - Oral
Cautions and warnings
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are taking medications for seizure, blood pressure, to suppress the immune system, to affect mental state or increase sedation, steroids or blood thinners (Wirtz et al. 2008; IOM 2004; Herxheimer and Petrie 2002; Lusardi et al. 2000; Maestroni 1993).
5 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have cardiovascular, immune, liver or kidney disease, seizure disorder, asthma or diabetes (Peschke and Mühlbauer 2010; Carrillo-Vico et al. 2005; IOM 2004; der Marderosian and Beuttlers 2003; Sutherland et al. 2003; Calvo et al. 2002; Herxheimer and Petrie 2002; Sutherland et al. 2002; Cagnacci et al. 2001a; Arangino et al. 1999; Sheldon 1998; Maestroni 1993).
12 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
When using this product avoid taking with alcohol or products that cause drowsiness (Herxheimer and Petrie 2002; Holliman and Chyka 1997).
2 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
When using this product avoid driving or using machinery for 5 hours (Avery et al. 1998; Suhner et al. 1998b).
2 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
Ask a health care practitioner/health care provider/health care professional/doctor/physician if sleeplessness persists for more than 4 weeks (chronic insomnia) (Buscemi et al. 2004; IOM 2004; Dipiro et al. 2002).
3 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
Contraindications
Do not use if you are pregnant or breastfeeding (IOM 2004).
1 study cited in the text has no matching reference in the monograph (see the anomalies listed on the sources page).
Known adverse reactions
Stop use if allergy occurs or if you experience headache, confusion, or nausea (Herxheimer and Petrie 2002).
1 study cited in the text has no matching reference in the monograph (see the anomalies listed on the sources page).
Health Canada monograph dated 19 December 2025
MELATONIN - Sublingual
Cautions and warnings
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are taking medications for seizure, blood pressure, to suppress the immune system, to affect mental state or increase sedation, steroids or blood thinners (Wirtz et al. 2008; IOM 2004; Herxheimer and Petrie 2002; Lusardi et al. 2000; Maestroni 1993).
5 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have a cardiovascular, immune, liver or kidney disease, seizure disorder, asthma or diabetes (Peschke and Mühlbauer 2010; Carrillo-Vico et al. 2005; IOM 2004; der Marderosian and Beuttlers 2003; Sutherland et al. 2003; Calvo et al. 2002; Herxheimer and Petrie 2002; Sutherland et al. 2002; Cagnacci et al. 2001a; Arangino et al. 1999; Sheldon 1998; Maestroni 1993).
12 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
When using this product avoid taking with alcohol or products that cause drowsiness (Herxheimer and Petrie 2002; Holliman and Chyka 1997).
2 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
When using this product avoid driving or using machinery for 5 hours (Avery et al. 1998; Suhner et al. 1998b).
2 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
Ask a health care practitioner/health care provider/health care professional/doctor/physician if sleeplessness persists for more than 4 weeks (chronic insomnia) (Buscemi et al. 2004; IOM 2004; Dipiro et al. 2002).
3 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
Contraindications
Do not use if you are pregnant or breastfeeding (IOM 2004).
1 study cited in the text has no matching reference in the monograph (see the anomalies listed on the sources page).
Known adverse reactions
Stop use if allergy occurs or if you experience headache, confusion, or nausea (Herxheimer and Petrie 2002).
1 study cited in the text has no matching reference in the monograph (see the anomalies listed on the sources page).
They concern the ingredient, not this product or its dose. They do not replace medical advice.
Other declarations with the same name
In France, every company that markets a supplement declares it, so one product can have several declarations (new formula, another distributor, an older declaration withdrawn). Each line compares the declared composition with this page.
- AMIX™ MELATONINE SLEEP FORMULA Amix Levante Sl, declared in 2026 : same declared composition
- AMIX™ MELATONINE SLEEP FORMULA Amix Levante Sl, declared in 2026 : same declared composition
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