MEA-SALICYLATE (salicylic acid monoethanolamine)

What official classifications and rules say for each group. A classification describes the hazard of the pure substance, not the risk of a product that contains it, which depends on the dose and the exposure.

Prohibition or serious classificationThe text prohibits the substance for this use, or ranks it among the most serious hazards (known or presumed carcinogenic, mutagenic or reprotoxic, identified endocrine disruptor).Worth watchingThe text sets a condition or flags a hazard worth knowing: allergen, suspected effect, condition for children, hazard to the aquatic environment.For informationOfficial information with no condition on a finished product: warning to read, irritation of the pure substance.

• Pregnancy and breastfeeding

  No classification harmonised by the European Union covers reproduction, the unborn child or breastfeeding for this substance. This does not mean it has been judged to have no effect during pregnancy.

• Babies and children

  Prohibition or serious classificationThe text prohibits the substance for this use, or ranks it among the most serious hazards (known or presumed carcinogenic, mutagenic or reprotoxic, identified endocrine disruptor).

  Prohibition or serious classification Annex V, entry 3, prohibits it in products intended for children under 3: “Not to be used in products for children under 3 years of age.”

  For a question about your own situation, ask your doctor, midwife or pharmacist.

• Skin, eyes and allergies

  No harmonised classification for sensitisation, irritation or eye damage, and no obligation to label it as an allergen.

• Environment

  No harmonised classification as hazardous to the aquatic environment, and it is not on ECHAEuropean Chemicals Agency.'s Candidate List as an endocrine disruptor for the environment.

• Read on the label

  For informationOfficial information with no condition on a finished product: warning to read, irritation of the pure substance.

  For information Annex V, entry 3, requires this to be printed on the pack: “Salicylic acid: Not to be used for children under 3 years of age** **Solely for products which might be used for children under 3 years of age. Salicylic acid salts: Not to be used for children under 3 years of age*** ***Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.”.

Allowed with restrictions

CosIng cites the name MEA-SALICYLATE in this entry, whose regulated name is “Monoalkylamines, monoalkanolamines and their salts”: the title below says which form or use it covers.

Maximum concentration

Maximum secondary amine content: 0.5%

Other conditions

- Do not use with nitrosating systems - Minimum purity: 99% - Maximum secondary amine content: 0.5% (applies to raw materials) - Maximum nitrosamine content: 50 microgram/kg - Keep in nitrite-free containers

Entry

Annex III, No 61

Substance

Monoalkylamines, monoalkanolamines and their salts

Preservative allowed under conditions

This entry covers the same substance as MEA-SALICYLATE (same CAS number in the CosIng inventory): its conditions apply.

Maximum concentration

Salicylic acid: 0.5% (acid) Salicylic acid salts: 0.5% (acid)

Other conditions

Salicylic acid: Not to be used in products for children under 3 years of age. Not to be used in oral products. Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. Salicylic acid salts: Not to be used in products for children under 3 years of age, except for shampoos.

Warning to print

Salicylic acid: Not to be used for children under 3 years of age** **Solely for products which might be used for children under 3 years of age. Salicylic acid salts: Not to be used for children under 3 years of age*** ***Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.

Entry

Annex V, No 3

Substance

Salicylic acid and its salts

Glossary names

SALICYLIC ACID, CALCIUM SALICYLATE, MAGNESIUM SALICYLATE, MEA- SALICYLATE, SODIUM SALICYLATE, POTASSIUM SALICYLATE, TEA- SALICYLATE

CAS

69-72-7[1]/ 824-35-1[2]/ 18917-89-0[3]/ 59866-70-5[4]/ 54-21-7[5]/ 578-36-9[6]/ 2174-16-5[7]

EC

200-712-3[1]/ 212-525-4[2]/ 242-669-3[3]/ 261-963-2[4]/ 200-198-0[5]/ 209-421-6[6]/ 218-531-3[7]

Identity

CosIng identifier

35191

CAS (according to CosIng)

59866-70-5

EC (according to CosIng)

261-963-2

Declared functions

Preservative

Wikidata

Q27236280

ECHA InfoCard

100.056.312

InChIKey

WGPVWXXJNUNBNB-UHFFFAOYSA-N

United Kingdom (Great Britain)

• Preservative allowed under conditions (Annex V)
• Cited as an example in a rule, no rule of its own (Annex III)

Same entries as in the European Union. Their maximum concentrations are compared in the “Comparison between countries” table; other conditions (product types, warnings) may differ.

Switzerland

Regulation (EC) No 1223/2009 applies in Switzerland (Article 54 of the Ordinance on Foodstuffs and Utility Articles).

United States, federal rules

None of the integrated sections of the federal code (21 CFR 700.11 to 700.27 and 250.250) targets this name. The FDA does not publish a list of allowed ingredients.

South Korea

• Restricted: 살리실릭애씨드 및 그 염류 (MEA-SALICYLATE)

  별표 2, 보존제 성분 (preservatives), entry 23, page 5-6. Limit: 살리실릭애씨드 로서 0.5%.

  Conditions, source text, in Korean

  비고: 영유아용 제품류 또는 만 13세 이하 어린이가 사용할 수 있음을 특정하여 표시하는 제품에는 사용금지(다만,샴푸는 제외) | 화학물질명: 살리실릭애씨드 (CAS No. 69-72-7) | 화학물질명: 칼슘살리실레이트 (CAS No. 824-35-1) | 화학물질명: 마그네슘살리실레이트 (CAS No. 18917-89-0) | 화학물질명: 엠이에이-살리실레이트 (CAS No. 59866-70-5) | 화학물질명: 소듐살리실레이트 (CAS No. 54-21-7) | 화학물질명: 포타슘살리실레이트 (CAS No. 578-36-9) | 화학물질명: TEA-살리실레이트 (CAS No. 2174-16-5) | 화학물질명: 베타인살리실레이트 (CAS No. 17671-53-3)

• Restricted: 살리실릭애씨드 및 그 염류 (MEA-SALICYLATE)

  별표 2, 기타 (other substances with limits), entry 38, page 33-34. Limit: ․인체세정용 제품류에 살리실릭애씨드로서 2% ․사용 후 씻어내는 두발용 제품류에 살리실릭애씨드로서 3%.

  Conditions, source text, in Korean

  비고: ․영유아용 제품류 또는 만 13세 이하 어린이가 사용할 수 있음을 특정하여 표시하는 제품에는 사용금지 (다만,샴푸는 제외) ․기능성화장품의 유효성분 으로 사용하는 경우에 한하며 기타 제품에는 사용금지 | 화학물질명: 살리실릭애씨드 (CAS No. 69-72-7) | 화학물질명: 칼슘살리실레이트 (CAS No. 824-35-1) | 화학물질명: 마그네슘살리실레이트 (CAS No. 18917-89-0) | 화학물질명: 엠이에이-살리실레이트 (CAS No. 59866-70-5) | 화학물질명: 소듐살리실레이트 (CAS No. 54-21-7) | 화학물질명: 포타슘살리실레이트 (CAS No. 578-36-9) | 화학물질명: 티이에이-살리실레이트 (CAS No. 2174-16-5) | 화학물질명: 베타인살리실레이트 (CAS No. 17671-53-3)

ASEAN (South-East Asia)

• Allowed preservative: Salicylic acid (69-72-7) and its salts(1): Calcium salicylate (CAS No. 824-35-1), Magnesium salicylate (CAS No. 18917-89-0), MEA-salicylate (CAS No. 59866-70-5), Sodium salicylate (CAS No. 54-21-7), Potassium salicylate (CAS No. 578-36-9), TEA-salicylate (CAS No. 2174-16-5)

  Annex VI (allowed preservatives), entry 3, page 268. Limit: 0.5% (acid) 0.5% (acid).

  Conditions, source text

  Limitations and requirements: Salicylic acid: Not to be used in products for children under three years of age. Not to be used in oral products. Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. Salicylic acid salts: Not to be used in preparations for children under three years of age, except for shampoos | Conditions of use and warnings which must be printed on the label: Salicylic acid: Not to be used for children under three years of age (2.1) Salicylic acid salts: Not to be used for children under three years of age (2.2) | Note (1): For non-preservative usage see Annex III. Part 1, entry 98 (2.1) Solely for products which might be used for children under three years of age (2.2) Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin

Taiwan

• Allowed preservative: Salicylic acid and its salts

  化粧品防腐劑成分名稱及使用限制表 (allowed preservatives). Limit: 0.5% (以acid計).

  Conditions, source text, in Chinese

  INCI：Salicylic acid ; Calcium salicylate ; Magnesium salicylate ; MEA-salicylate ; Sodium salicylate ; Potassium salicylate ; TEA-salicylate | 限制規定：除洗髮產品外，不得使用於三歲以下孩童之產品。 | 應刊載之注意事項：不得使用於三歲以下孩童。(洗髮產品得免刊載該注意事項)

Brazil

• Allowed under conditions: Ácido salicílico e seus sais (*) (a)SALICYLIC ACID b) CALCIUM SALICYLATE/ MAGNESIUM SALICYLATE/MEA-SALICYLATE/ SODIUM SALICYLATE/ POTASSIUM SALICYLATE/TEA-SALICYLATE)

  RDC 528/2021, Anexo (allowed preservatives), entry 4, page 2;3. Limit: a) e b) 0.5% (expresso como ácido).

  Conditions, source text, in Portuguese

  LIMITAÇÕES: a) -Proibido em produtos para crianças menores de 3 anos. - Proibido em produtos para uso bucal. - Proibido em produtos cuja aplicação possa conduzir à exposição pela via de inalação. b) Proibido em produtos para crianças menores de 3 anos, com exceção dos xampus com enxágue. | CONDIÇÕES DE USO E ADVERTÊNCIAS: a) -Para produtos de uso adulto: "Não usar em crianças". -Para produtos destinados ao público infantil: "Não usar em crianças menores de 3 anos”. b)-Para produtos de uso adulto: "Não usar em crianças". -Para produtos destinados ao público infantil, exceto para xampus com enxágue: "Não usar em crianças menores de 3 anos”.