Biweekly Updates of Global Regulations on Cosmetics


 

SCCS - Final Opinion on the Safety of aα-arbutin and β-arbutin in Cosmetic Products

On 1 February 2023, Scientific Committee on Consumer Safety (SCCS) released its final opinion on the safety of α-arbutin and β-arbutin in cosmetic products.  The SCCS is of the opinion that aggregate exposure of alpha-arbutin (2% in face cream and 0.5% in body lotion) with

beta-arbutin (7% in face cream) is considered safe.

 


SCCS - Final Opinion on the Safety of Aluminum in Cosmetic Products

On 2 February 2023, Scientific Committee on Consumer Safety (SCCS)

released its final opinion on the safety of aluminum in cosmetic products. The SCCS is of the opinions:

1. Aluminum compounds are safe when used in non-sprayable product categories at the maximum levels indicated in Table 4 and Table 6.

2. Aluminum compounds are considered safe in sprayable products, at the maximum levels indicated in Table 4, provided that the percentage of particles/droplets with a diameter of less than 10 μm does not exceed 20% of the total aerosolised particles/droplets. Since the Applicant’s data submission indicated that aluminum is not used in sunscreen aerosol sprays, this Opinion does not cover sunscreen aerosol sprays.

3. As aluminum does not belong to substances classified as CMR 1A or B, only exposure from cosmetic uses was considered in this safety assessment with the exposure assessment based on maximum use levels for cosmetic ingredients.

However, the aggregate exposure to aluminum from cosmetic and non-cosmetic sources may exceed safe limits for consumers at the highest exposure ranges.

 


SCCS - Request for a Scientific Opinion on Water-Soluble Zinc Salts Used in Oral Products

Water-soluble zinc compounds are used in oral cosmetic products to reduce oral malodour, tartar, and plaque formation. Newly submitted dossiers and data require the Scientific Committee on Consumer Safety (SCCS) to reconsider the current regulations on the safe use of it. Therefore, on 3 February 2023, the SCCS published a request for a scientific opinion on water-soluble Zinc salts on the following questions:

1. Does the SCCS consider that water soluble zinc salts are safe up to 1 % (as zinc) in toothpaste and 0.1% (as zinc) in mouthwash, for both adults and children? If not, the SCCS is requested to provide safe concentrations for each age group.

2. Does the SCCS consider that the contribution of cosmetic products among the overall/total exposure to zinc is still of concern?

Stakeholders have 9 months to submit scientific opinions and data.

 


SCCS-Minutes on Cosmetic Ingredients

On 7 February 2023, the Scientific Committee on Consumer Safety (SCCS) released a minutes on a meeting, held in Luxembourg from 30-31 January to discuss the safe use of some cosmetic ingredients. The following list of points is discussed.

1. New Mandates or information on Hexylsalicylate, Hair dye HC blue 18, Zn salts in oral products, and salicylates.

2. Discussions on draft opinions of citral, sliver zinc zeolite, TiO2 scientific advice in oral and inhalation cosmetic products, methysalicylate, butylparaben, hair dye ingredient hydroxypropyl p-phenylenediamine and its dihydrochloride salt, and Benzyl salicylate.

3. Comments on opinions of salicylic acid, Hair dye C186final opinions on arbutins and aluminum.

 

 

Bans on PFAS Proposed in European Union

In January 2023, Germany, Denmark, Norway, Netherlands and Sweden submitted a proposal to the European Chemicals Agency (ECHA) to restrict per- and polyfluoroalkyl substances (PFAS) under REACH. It is due to their concerns over environmental exposure and accumulation, as well as potential toxicity to human health.

The U.S. Food and Drug Administration (FDA) previously reported on PFAS in cosmetics, citing their use in lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow and mascara. Functions include conditioning and smoothing the skin, or adjusting product consistency and texture.

The ECHAs scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will now review the proposal to ensure it meets the legal requirements of REACH. Meetings are scheduled to begin on March 22, 2023.

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