EU-SCCS Revised Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation
On 16 May 2023, the EU Scientific Committee of Consumer Safety (SCCS) released notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation (12th Revision), updating with main changes on the following:
• Importance of systematic literature review
• Updating of animal-free alternative methods: NAM (New Approach Methodology),
changes introduced for acute inhalation, skin irritation testing, eye irritation testing
with DAL (Defined Approach for eye irritation, Liquid), DASS (Defined Approaches
for Skin Sensitisation), new in vitro methods for genotoxicity testing (3D skin
Comet; in vitro micronucleus)
• Importance of AOP (Adverse Outcome Pathway), DAs (Defined Approaches), IATA
(Integrated Approaches to Testing and Assessment), NGRA (Next Generation Risk
Assessment) with definition of BER (Bioactivity/Exposure Ratio), TTC (Threshold of
Toxicological Concern), iTTC (internal TTC)
• Updating of in silico prediction possibilities
• Exposure data reviewed (models, parameters specific for inhalation, aggregate
exposure)
• Exposure of children to different cosmetic product categories according to age
• Sun protection by sunscreen products: rationale behind exposure data
• Human biomonitoring (HBM) and differences with SCCS approach for risk
assessment
• CMRs reporting requirements
• Endocrine active substances, introduction of non-monotonic dose response,
reporting requirements
• Templates for PBTK (Physiologically Based ToxicoKinetics) model description and
parameter verification and analysis
EU-SCCS Released Scientific Advice on Children Exposure on Mythyl Salicylate
On 16 May 2023, the EU Scientific Committee of Consumer Safety (SCCS) released its scientific advice on children's exposure on Mythyl Salicylate.
the SCCS considers the use of Methyl Salicylate as safe in cosmetic products intended for children of age 0.5-3 years when used up to a maximum concentration of 0.02% in shower gel, hand soap, shampoo, body lotion, face cream, hand cream, lip products. For toothpaste up to a maximum concentration of 2.52% methyl salicylate is considered safe.
the SCCS considers the use of Methyl Salicylate as safe in cosmetic products intended for children of age 3-6 years in shower gel, hand soap, shampoo, body lotion, face cream, hand cream, lip products, hair conditioner up to the allowed maximum concentrations indicated in Table 1. For toothpaste up to a maximum concentration of 2.52% methyl salicylate is considered safe.
Table 1 Currently allowed concentrations of Methyl Salicylate in cosmetic products
|
Product type, Body parts |
Maximum concentration in ready-for-use preparation |
Other |
|
(a) Leave-on skin products (except face makeup, spray/aerosol body lotion, spray/aerosol deodorant and hydroalcoholic-based fragrances) and leave on hair products (except spray/aerosol products) |
(a) 0.06 % |
Not to be used in preparations for children under 6 years of age, with the exception of (k) “Toothpaste |
|
(b) Face makeup (except lip products, eye makeup and makeup remover) |
(b) 0.05 % |
|
|
(c) Eye makeup and makeup remover |
(c) 0.002 % |
|
|
(d) Leave-on hair products (spray/aerosol) |
(d) 0.009 % |
|
|
(e) Deodorant spray/aerosol |
(e) 0.003 % |
|
|
(f) Body lotion spray/aerosol |
(f) 0.04 % |
|
|
(g) Rinse-off skin products (except hand wash) and rinse-off hair products |
(g) 0.06 % |
|
|
(h) Hand wash |
(h) 0.6 % |
|
|
(i)Hydroalcoholic-based fragrances |
(i) 0.6 % |
|
|
(j) Lip products |
(j) 0.03 % |
|
|
(k) Toothpaste |
(k) 2.52 % |
|
|
(l)Mouthwash intended for children aged 6–10 years |
(l) 0.1 % |
|
|
(m) Mouthwash intended for children above 10 years of age and adults |
(m) 0.6 % |
|
|
(n) Mouth spray |
(n) 0.65 % |
New Zealand Proposed to Amend the Cosmetics Products Group Standard
On 14 March 2023, New Zealand notified the WTO of a proposal to amend its Cosmetic Products Group Standard 2020. In particular, the text provides for the alignment of the “Ingredients” annexes with those of the European Cosmetics Regulation 1223/2009. It also introduces a future ban on PFAS, additional requirements on nanomaterials, and the integration of the latest IFRA Standards.
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