Scientific Opinion on the substantiation of health claims related to
methylsulphonylmethane (MSM) and contribution to normal collagen
formation (ID 353, 388, 389, 394, 1695, 1741, 1874), maintenance of normal
hair (ID 353, 1741, 1874), maintenance of normal nails (ID 1695, 1741,
1874), maintenance of normal acid-base balance (ID 387), “strengthens the
immune system function” (ID 390), maintenance of normal bowel function
(ID 391), contribution to the normal cysteine synthesis (ID 392) and
“vitamin production needed for correct function of metabolism” (ID 393)
pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3
European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe:
Methylsulphonylmethane (MSM)
acid-base balance
bowel function
collagen
cysteine
hair
health claims
immune system
nails
vitamins
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is methylsulphonylmethane (MSM).
Methylsulphonylmethane (MSM) is an organic sulphur-containing compound containing around 34 % sulphur that occurs naturally in a variety of fruits, vegetables, grains and animals. MSM is measurable in foods by established methods.
The Panel considers that the food constituent, methylsulphonylmethane (MSM), which is the subject of the health claims is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Udział w prawidłowym tworzeniu kolagenu (ID 353, 388, 389, 394, 1695, 1741, 1874)
The claimed effects are “essential part of the connective tissues, skin and hair”, “regeneration of cartilage”, “supports the human motion mechanism - might help with production of collagen”, “important for collagen synthesis in cartilage and for structure of bones, joints, teeth, hair and nails”, “skin and annexes health”, “anti-aging”, and “to help strengthen hair, skin and nails”. The Panel assumes that the target population is the general population.
The Panel assumes that the claimed effect refers to collagen formation. Collagen is a structural component of several tissues in the body including cartilage, connective tissue, skin, gums, joints and bone.
The Panel considers that contribution to normal collagen formation is a beneficial physiological effect.
2.2. Utrzymanie prawidłowego stanu włosów (ID 353, 1741, 1874)
The claimed effects are “essential part of the connective tissues, skin and hair”, “anti-aging”, and “to help strengthen hair, skin and nails”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the maintenance of normal hair.
The Panel considers that maintenance of normal hair is a beneficial physiological effect.
2.3. Utrzymanie prawidłowego stanu paznokci (ID 1695, 1741, 1874)
The claimed effects are “skin and annexes health”, “anti-aging”, and “to help strengthen hair, skin and nails”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the maintenance of normal nails.
The Panel considers that maintenance of normal nails is a beneficial physiological effect.
2.4. Utrzymanie prawidłowej równowagi kwasowo-zasadowej (ID 387)
The claimed effect is “pH balance”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel assumes that the claimed effect refers to acid-base balance.
The Panel considers that maintenance of normal acid-base balance is a beneficial physiological effect.
2.5. Wzmocnienie układu odpornościowego podczas leczenia opryszczki (ID 390)
The claimed effect is “strengthens the immune system function”. The Panel assumes that the target population is the general population.
In the context of the clarification provided by Member States, the Panel assumes that the claimed effect refers to the treatment of cold sores and herpes.
The Panel considers that treatment of cold sores and herpes constitutes a treatment of a disease.
The Panel considers that the claim does not comply with the criteria laid down in Regulation (EC) No 1924/2006.
2.6. Utrzymanie prawidłowego funkcjonowania jelit (ID 391)
The claimed effect is “gastrointestinal system”. The Panel assumes that the target population is the general population.
In the context of the clarifications provided by Member States, the Panel assumes that the claimed effect refers to maintenance of normal bowel function. Changes in bowel function within the normal range e.g. reduced transit time, increased frequency of bowel movements or bulk of stools might be interpreted as improvement of bowel function.
The Panel considers that maintenance of normal bowel function might be a beneficial physiological effect.
2.7. Udział w prawidłowej syntezie cysteiny (ID 392)
The claimed effect is “synthesis of amino acids”. The Panel assumes that the target population is the general population.
In the context of the clarifications provided by Member States, the Panel notes that the claimed effect refers to the synthesis of sulphur containing amino acids. The two sulphur containing proteinogenic amino acids in the human body are methionine and cysteine. Methionine is an essential amino acid which cannot be synthesised in the body. Therefore, the Panel assumes that the claimed effect refers to the synthesis of cysteine.
The Panel considers that contribution to the normal cysteine synthesis is a beneficial physiological effect.
2.8. Produkcja witamin potrzebnych do prawidłowego funkcjonowania metabolizmu (witamina C, H, B5, B13) (ID 393)
The claimed effect is “metabolism of vitamins”. The Panel assumes that the target population is the general population.
In the context of the proposed wording and the clarifications provided by Member States, the Panel notes that the claim refers to “vitamin production needed for correct function of metabolism” and “supports the production of vitamin C, H, B5, B13”. Vitamin C, biotin and pantothenic acid are essential nutrients which cannot be synthesised by the human body, while vitamin B13, which is an old terminology for orotic acid, is not a vitamin.
The Panel notes that “vitamin production needed for correct function of metabolism” in the context of “supports the production of vitamin C, H, B5, B13” cannot be considered as a health relationship applicable to humans.
The Panel considers that the claim does not comply with the criteria laid down in Regulation (EC) No 1924/2006.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka
3.1. Udział w prawidłowym tworzeniu kolagenu (ID 353, 388, 389, 394, 1695, 1741, 1874)
Eleven references were cited to substantiate the claim. One reference was a textbook. One was a website where the source of information could not be determined. An unpublished pilot study on a combination of polyamines and MSM as well as one human study with MSM, a case report and an in vitro study dealt with outcomes unrelated to the claimed effect. One reference was a review not related to the food constituent that is the subject of the health claim. Another review on sulphur containing metabolites did not mention the claimed effect. Two references were animal studies on the toxicity of MSM. The remaining reference was a human study on the use of MSM against osteoarthritis pain of the knee which did not address the claimed effect. The Panel considers that no conclusions could be drawn from these references for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of MSM and contribution to normal collagen formation.
3.2. Utrzymanie prawidłowego stanu włosów (ID 353, 1741, 1874)
Four references were cited to substantiate the claim. One reference was a review not related to the food constituent that is the subject of the health claim. A review on sulphur-containing metabolites did not mention the claimed effect. Two references were animal studies on the toxicity of MSM. The Panel considers that no conclusions could be drawn from these references for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of MSM and maintenance of normal hair.
3.3. Utrzymanie prawidłowego stanu paznokci (ID 1695, 1741, 1874)
Three references were cited to substantiate the claim. Two references were animal studies on the toxicity of MSM. The Panel considers that no conclusions could be drawn from these references for the scientific substantiation of the claimed effect.
One reference was an unpublished pilot study on a combination of polyamines and MSM on the treatment of common onychodystrophy. The Panel notes that no conclusions could be drawn from a study on a fixed combination for the scientific substantiation of the claim on MSM alone.
The Panel concludes that a cause and effect relationship has not been established between the consumption of MSM and maintenance of normal nails.
3.4. Utrzymanie prawidłowej równowagi kwasowo-zasadowej (ID 387)
Three references were cited to substantiate the claim. All of the references dealt with outcomes unrelated to the claimed effect. The Panel considers that no conclusions could be drawn from these references for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of MSM and maintenance of normal acid-base balance.
3.5. Utrzymanie prawidłowego funkcjonowania jelit (ID 391)
One reference was cited to substantiate the claim which was a conference presentation in which it was mentioned that relief of chronic constipation had been observed in patients of a clinic when MSM was administered in doses between 100 and 500 mg. The information provided regarding the study design, methodology and statistical analyses was insufficient for a complete scientific evaluation. The Panel considers that no conclusions could be drawn from this reference for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of MSM and normal bowel function.
3.6. Udział w prawidłowej syntezie cysteiny (ID 392)
One reference was cited to substantiate the claimed effect which was a reference to Wikipedia in which the claimed effect was not mentioned. The Panel considers that no conclusions could be drawn from this reference for the scientific substantiation of the claimed effect.
The Panel notes that MSM is not a precursor of cysteine.
The Panel concludes that a cause and effect relationship has not been established between the consumption of MSM and contribution to the normal cysteine synthesis.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, methylsulphonylmethane (MSM), which is the subject of the health claims is sufficiently characterised.
Contribution to normal collagen formation (ID 353, 388, 389, 394, 1695, 1741, 1874)
The claimed effects are “essential part of the connective tissues, skin and hair”, “regeneration of cartilage”, “supports the human motion mechanism - might help with production of collagen”, “important for collagen synthesis in cartilage and for structure of bones, joints, teeth, hair and nails”, “skin and annexes health”, “anti-aging”, and “to help strengthen hair, skin and nails”. The target population is assumed to be the general population. Contribution to normal collagen formation is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of MSM and contribution to normal formation of collagen.
Maintenance of normal hair (ID 353, 1741, 1874)
The claimed effects are “essential part of the connective tissues, skin and hair”, “anti-aging”, and “to help strengthen hair, skin and nails”. The target population is assumed to be the general population. Maintenance of normal hair is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of MSM and maintenance of normal hair.
Maintenance of normal nails (ID 1695, 1741, 1874)
The claimed effects are “skin and annexes health”, “anti-aging”, and “to help strengthen hair, skin and nails”. The target population is assumed to be the general population. Maintenance of normal nails is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of MSM and maintenance of normal nails.
Maintenance of normal acid-base balance (ID 387)
The claimed effect is “pH balance”. The target population is assumed to be the general population. Maintenance of normal acid-base balance is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of MSM and maintenance of normal acid-base balance.
“Strengthens the immune system function” (ID 390)
The claimed effect is “strengthens the immune system function”. The target population is assumed to be the general population. The clarification provided by Member States refers to the treatment of cold sores and herpes which is considered to constitute a treatment of a disease.
The claim does not comply with the criteria laid down in Regulation (EC) No 1924/2006.
Maintenance of normal bowel function (ID 391)
The claimed effect is “gastrointestinal system”. The target population is assumed to be the general population. Maintenance of normal bowel function might be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of MSM and maintenance of normal bowel function.
Contribution to the normal cysteine synthesis (ID 392)
The claimed effect is “synthesis of amino acids”. The target population is assumed to be the general population. In the context of the clarifications provided by Member States, it is assumes that the claimed effect relates to the synthesis of cysteine. Contribution to the normal cysteine synthesis is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of MSM and contribution to the normal cysteine synthesis.
“Vitamin production needed for correct function of metabolism” (ID 393)
The claimed effect is “metabolism of vitamins”. The target population is assumed to be the general population. In the context of the proposed wording and the clarifications provided by Member States, it is noted that the claim refers to “vitamin production needed for correct function of metabolism” and “supports the production of vitamin C, H, B5, B13”, which cannot be considered as a health relationship applicable to humans.
The claim does not comply with the criteria laid down in Regulation (EC) No 1924/2006.
