TheDose

Benzyl Salicylate

Also known as Benzyl salicylate, Benzyl 2-hydroxybenzoate, 2-Hydroxybenzoic acid, phenylmethyl ester

CIRSCCSEU CosIngPubMed

Safe with conditions

CIR Expert Panel says: restricted.”

Benzyl salicylate is a fragrance ingredient (ester of benzyl alcohol and salicylic acid) used widely in perfumes and cosmetics. The 2019 CIR Final Report (FR778) concluded it is safe with a Qualified Safety (SQ) finding — safe when formulated to be non-irritating and non-sensitizing, which may be based on a QRA — acknowledging its sensitization potential at higher concentrations. The 2023 SCCS Final Opinion (SCCS/1656/23) provides updated EU safety assessment confirming safety at product-category-specific maximum concentrations (Table 1), with MoS >100 for all categories; weak estrogenic activity was noted but the SCCS found no evidence of adverse endocrine effects at cosmetic use levels. Under EU Regulation 1223/2009, benzyl salicylate is listed in Annex III (Entry 75) as a regulated fragrance allergen requiring label declaration when present above 0.001% in leave-on products or 0.01% in rinse-off products. It is NOT listed in Annex V (preservatives) or Annex VI (UV filters) — fragrance allergen status is the binding regulatory constraint.


Widely used fragrance ingredient providing floral, balsamic, and sweet odor notes in perfumes, personal care products, and household products

Dual function as both fragrance carrier and mild UV absorber (absorbs UVB), though not approved as a UV filter under EU Annex VI

Well-characterized safety profile with two independent authoritative reviews (CIR 2019, SCCS 2023) providing category-specific safe use concentrations

SCCS MoS >100 for all assessed product categories confirms adequate safety margins at current industry use concentrations


Concerns
  • · Regulated EU fragrance allergen (Annex III Entry 75): label declaration required above 0.001% (leave-on) or 0.01% (rinse-off) due to sensitization potential in susceptible individuals
  • · CIR SQ finding: formulations must be non-irritating and non-sensitizing; RIFM QRA recommended for fragrance use concentrations
  • · SCCS/1656/23 noted weak estrogenic activity in vitro; however, MoS calculations at actual use concentrations gave margins >100, and SCCS concluded no adverse endocrine effects at cosmetic use levels
  • · High-concentration fragrance applications (e.g., fine fragrance at 4%) are at the upper bound of SCCS-assessed safety margin; concentration discipline important for leave-on product formulations

CIR Expert Panel
Restricted
Safe when formulated to be non-irritating and non-sensitizing, which may be based on a quantitative risk assessment (QRA) — CIR FR778, June 2019
EU CosIng
Restricted
Annex III Entry 75: fragrance-allergen disclosure required (>0.001% leave-on / >0.01% rinse-off)
EU SCCS
Restricted
Safe at concentrations in SCCS/1656/23 Table 1 (e.g., fragrance 4%, body lotion 0.7%, rinse-off hair products 1.3%, rinse-off body/face 0.5%, toothpaste 0.004%); MoS >100 for all product categories; weak estrogenic activity noted but no adverse endocrine effects at use levels
[1]
CIR Expert Panel · Jun 26, 2019Live

Safety Assessment of Benzyl Salicylate As Used in Cosmetics — CIR Final Report FR778 (June 26, 2019): Finding=SQ (safe when formulated to…

Benzyl Salicylate is safe in cosmetics in the present practices of use and concentration described in the safety assessment when formulated to be non-irritating and non-sensitizing, which may be based on a quantitative risk assessment (QRA).bensal042019FR.pdf, Abstract (p. 1)
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[2]
EU SCCS · Oct 26, 2023Document match

SCCS/1656/23 Final Opinion on Benzyl Salicylate (CAS 118-58-1), adopted 26 October 2023 — safe at max concentrations in Table 1; MoS >100…

the SCCS considers benzyl salicylate safe when used as a fragrance ingredient in cosmetic products at the concentrations specified in Table 1 of this Opinionsccs_o_277.pdf, Opinion (Conclusion)
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[3]
EU CosIng · Nov 30, 2009Document match

EU Regulation 1223/2009 Annex III (Restricted Substances) — Entry 75: Benzyl Salicylate, CAS 118-58-1; fragrance allergen labeling requir…

Entry 75, Benzyl Salicylate, CAS 118-58-1; must be indicated in ingredient list per Art 19(1)(g) when concentration exceeds 0,001% in leave-on products or 0,01% in rinse-off productsEU Reg 1223/2009 Annex III, Entry 75
Verificationweb_textView source
[4]
Peer-reviewed (PubMed) · Jan 1, 2007

RIFM Fragrance Ingredient Safety Assessment, Benzyl Salicylate (Lapczynski A et al., Food Chem Toxicol 45(Suppl 1):S362-S380, 2007)

Verificationweb_textView on PubMed
Sources
4
PubMed citations
1
Evidence quality
moderate
Last verified
Re-reviewed when a new CIR / SCCS opinion publishes.